Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204588
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2023-12-14
Brief Title:
Evaluation of Regenerative Potential in Horizontal Bone Loss Using VCMX Along With LASER Therapy
Sponsor:
Postgraduate Institute of Dental Sciences Rohtak
Organization:
Postgraduate Institute of Dental Sciences Rohtak
Study Overview
Official Title:
Clinical and Radiographic Evaluation of Volume Stable Collagen Matrix VCMX in the Regenerative Outcome of Periodontal Horizontal Bone Loss When Used With Diode Laser Therapy in Humans A Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background- Periodontitis an inflammatory disease of the periodontium is one of the major causes of tooth mortality Of all the bone destruction patterns that are present in periodontitis horizontal bone loss is the most common Therefore treatment modalities that help in rebuilding horizontal defects are vital in total periodontal reconstruction
Rationale- The supracrestal bone regeneration in cases of horizontal bone loss has remained a mirage with very little recorded success Volume stable collagen matrixVCMX is a porous cross-linked collagen matrix of porcine origin designed to facilitate cell and vascular ingrowth and soft-tissue volume augmentation may be beneficial in maintaining the supracrestal space and may overcome the limitation of bone regeneration in horizontal defects Evidence has shown that Low level laser therapyLLLT based on principal of biostimulation of osteoclastic cells can have a positive effect on the regeneration of supracrestal bone in horizontal bone destruction So this study will be first of its kind using combination of VCMX with LLLT to assess regenerative outcome in treatment of horizontal bone destruction in patients with periodontitis
Objectives To assess clinical and radiographic regenerative outcome of periodontal tissues using LLLT and placing VCMX with single flap approachSFA in treatment of horizontal bone loss as compared to LLLT and SFA
Method A total of 60 patients will be randomly divided into three groups Test Group 1 VCMX LLLT SFA Test Group 2LLLTSFA and Control group SFA Periodontal parameters will be evaluated at baseline 3 6 and 9 months CBCT will be evaluated at baseline and 9 months
Expected outcome VCMX with Laser could achieve supracrestal bone regeneration in horizontal bone loss
Rationale- The supracrestal bone regeneration in cases of horizontal bone loss has remained a mirage with very little recorded success Volume stable collagen matrixVCMX is a porous cross-linked collagen matrix of porcine origin designed to facilitate cell and vascular ingrowth and soft-tissue volume augmentation may be beneficial in maintaining the supracrestal space and may overcome the limitation of bone regeneration in horizontal defects Evidence has shown that Low level laser therapyLLLT based on principal of biostimulation of osteoclastic cells can have a positive effect on the regeneration of supracrestal bone in horizontal bone destruction So this study will be first of its kind using combination of VCMX with LLLT to assess regenerative outcome in treatment of horizontal bone destruction in patients with periodontitis
Objectives To assess clinical and radiographic regenerative outcome of periodontal tissues using LLLT and placing VCMX with single flap approachSFA in treatment of horizontal bone loss as compared to LLLT and SFA
Method A total of 60 patients will be randomly divided into three groups Test Group 1 VCMX LLLT SFA Test Group 2LLLTSFA and Control group SFA Periodontal parameters will be evaluated at baseline 3 6 and 9 months CBCT will be evaluated at baseline and 9 months
Expected outcome VCMX with Laser could achieve supracrestal bone regeneration in horizontal bone loss
Detailed Description:
Periodontitis is a chronic inflammatory disease triggered by gram-negative anaerobic microbes and involves chronic inflammation that causes the destruction of the tooth-supporting apparatus and can lead to tooth loss1 Periodontal disease is responsible for decreasing alveolar bone height along with morphologic changes of alveolar bone Various pattern of bone loss was observed clinically horizontal and vertical pattern of bone loss are most commonly seen in periodontitis cases2 Various factors that determine bone loss patterns are teeth alignments in arch root position within the alveolar socket and root proximity with the adjacent tooth surface3 Kern et al in 1984 called this horizontal bone defect as zero wall defects In this type of defect bone margin reduction occurs horizontally and its margin lies perpendicular to tooth surface Horizontal pattern of bone loss is most commonly seen in human dentition4 but it receives very less attention in terms of treatment modalities The prevalence of vertical bone loss was 78 with treatment choices of 968 while the horizontal bone loss prevalence rate was 922 and undergo 32 treatment options only5 Due to no bone wall remaining for the support and stability of grafts and membranes leads to a very low success rate of horizontal bone defects treatment modalities To regenerate the lost part of the alveolar bone is always a challenge for both clinician and patient
Several attempts have been done for the treatment of horizontal bone defects using bone grafts membranes or a combination of grafts and membranes Recently recombinant human bone morphogenic protein rhBMP and enamel matrix proteinsEMPs have been assessed for the management of horizontal defects But their results were mixed and sometimes disappointing The single flap approach SFA is a simplified minimally invasive surgical approach that enhances primary closure and minimizes tissue trauma The principle behind using this approach is that elevation of the limited mucoperiosteal flap allows surgical access from either the buccal or palatallingual aspect only depending on the extension of the lesion leaving the interdental supracrestal gingival tissue intact Main advantages associated with this approach that flap repositioning and suturing to the undetached papilla thereby preventing contamination by blood clots and reduction in post-surgical reduction Due to the emergence of biologic approach and biomaterials there is improved concern toward of horizontal defects Various factors determine the outcomes like patient-related factors site-related and clinician related factors Laser technology now a days becoming popular in various medical applications like photodynamic therapy Low level laser therapy LLLT also called photo-biomodulation enhance wound healing based on the principle of biomodulatory capacity of laser on body cells leading to increased cell activity12 It reduces excessive post-operative inflammation edema and pain LLLT can promote bone regeneration by enhancing proliferation and differentiation of human osteoblasts14 According to Gavish et al 780nm diode laser shown to inhibit the gene expression of pro-inflammatory cytokines interleukin-1 betaIL-1β modulate matrix metalloproteinase MMPs activity15 and reduce monocyte chemotactiprotein-1 MCP-1 IL-1α IL-10 and IL-6 in lipopolysaccharide-stimulated macrophages16 Numerous treatment approaches for restoring such defects have been investigated Despite laudable record autografts have been questioned for surgical invasiveness donor site morbidity limited quantity of donor material and increased operating time for harvesting procedures17 Limitations of the use of osteoinductive grafts is variation in bone induction capacity sourced from different tissue banks1819 When used in intrabony defects Enamel Matrix DerivativeEMD may restrict the space provision potential of the preparation20 Further application of EMD is a technique sensitive procedures and contamination of the material jeopardizing the regenerative potential The lack of rigidity and rapid degradation biodegradability make the use of PRF for periodontal regeneration difficult Nanocomposites and nanostructured materials are thought to have a key function in hard tissue research since natural bone tissue is a distinctive model of a nanocomposite Collagen has been potentially used in periodontal tissue engineering The integration of collagen as a structural protein serving as an essential component of connective tissue into three-dimensional scaffolds implanted after periodontal injury necrosis or inflammation has attracted much attention in tissue regeneration
According to Ibara et al scaffolds to be implanted are durable if composed of nanoparticles The nanoparticles facilitate healing process in contact with the tissues intended for the reformation Recently Thoma et al developed and tested collagen-based matrices as potential devices for soft tissue volume augmentation Volume stable collagen matrix VCMX is able to overcome the volume stability limitation of most commercially available grafts21 It is one of the most biocompatible novel material to be used in this study While mechanical stability is achieved by chemical crosslinking mechanical testing demonstrated preserved elasticity of the material over 14 days22 It has shown quite impressive results in resolving the intrabony defects in animal studies with an average of 5856 of new bone formation 23 Imber J-C et al23 preclinically evaluated the effect of a volume-stable collagen matrix on periodontal regeneration in two-wall intrabony defects This study provided histologic evidence for the potential of this novel VCMX to facilitate periodontal regeneration Asparuhova MB et al24 investigated the influence of a novel volume-stable collagen matrix VCMX on early wound healing events including cellular migration and adhesion protein adsorption and release and the dynamics of the hemostatic system Their study concluded that their data strongly support the effect of the novel VCMX on fibrin clot stabilization and coagulationfibrinolysis equilibrium thus facilitating progression to the next stages of the soft tissue healing process
Therefore the present study was planned to evaluate the supracrestal regenerative potential of volume stable collagen matrix VCMX along with single flap approachSFA when used with diode laser in the treatment of horizontal bone defect of stage 2 and 3 patients in comparison to OFD with diode laser and OFD alone
Methodology
Study design and settings The study design is Randomized controlled clinical trial and will be conducting in Department of Periodontology Post graduate Institute of Dental Sciences Rohtak Haryana
Study population
Systemically healthy patients with periodontitis stage 2 and stage 3 having horizontal bone loss will be enrolled in the present study
I Study conduct Patients will be enrolled according to inclusion and exclusion criteria from the outpatient department of periodontics Post Graduate Institute of Dental Sciences Rohtak Haryana Informed and written consent will be taken from each patient in his or her language
Randomization of patients would be done by generating the allocation sequence using computer-generated table by another investigator Patients will be randomly allocated into
Control group using single flap approach only
Test group 1 using collagen matrix and laser therapy in horizontal bone loss defects by single flap approach SFAVCMXLLLT
Test group 2 Single flap approach along with diode laser SFALLLT A balanced permuted block approach in blocks of four and six patients will be used to prepare the randomization tables After the debridement of the bone defect the eligibility of the bone defect would be confirmed Allocation concealment will be performed by opaque sealed envelopes that would be opened after debridement of horizontal bone loss defects and the surgeon will be informed of the allocated treatment Although the surgeon wont be blinded to the treatments the examiners recording clinical and radiographic parameters would be blind to the treatment groups Minimum One horizontal bone defect per patient will be included in the study
Periodontal parameters
Parameters recorded for experimental and adjacent teeth will include PIaque index PI and Gingival Index GI assessed at six surfaces mesiobuccal midbuccal distobuccal midlingualmidpalatal mesiolingual distolingual bleeding on probing BOP PPD CAL and gingival recession REC examined at six surfaces mesiobuccal midbuccal disto-buccal mesiolingualmesiopalatal midlingualmidpalatal distolingualdistopalatal
Radiographic Parameters that will be assessed using CBCT will include alveolar crest changes ACCOutcome measures will be revaluated at 3 6 9 months interval
Intervention
Presurgical patient preparation
Patients diagnosed with periodontitis who will meet the inclusion criteria will be screened for periodontal examination Based on this examination target sites will be identified Each patient will receive the initial phase of the therapy which will include oral hygiene instructions supragingival and subgingival debridement using ultrasonic Piezon EMS Dental Nyon Switzerland and hand instrumentations Gracey CurettesHu- Friedy Chicago IL USA and relieving of occlusal trauma
Surgical procedure
Surgical sites will be anaesthetized using local anaesthesia Simplified Papilla Preservation flap technique will be exercised using single flap approach Crevicular incisions will be made on buccallingualpalatal sites to raise a full-thickness mucoperiosteal flap Precaution would be taken to preserve the maximum interdental gingival tissue at the time of crevicular incision and no bone recontouring would be performed Thorough debridement of the surgical site would be performed For the test group1 VCMX would be placed according to the dimensions of the horizontal bone loss defect along with the use of diode laser LLLT on the inner epithelium of flap For the test group 2 SFA will be done along with the use of diode laser LLLT For control group SFA will be done And after this flap would be approximated and sutured at the original position with a monofilament suture material using interrupted sutures
Instructions for maintenance of proper oral hygiene will be reinforced Study participants will be scheduled for a follow-up visit weekly to1-month postsurgery and subsequently at 3- 6- and 9-month intervals
All statistical tests will use two-sided P values and statistical software will be used in the analysis of the study data Differences associated with P values 005 will be considered statistically significant
Several attempts have been done for the treatment of horizontal bone defects using bone grafts membranes or a combination of grafts and membranes Recently recombinant human bone morphogenic protein rhBMP and enamel matrix proteinsEMPs have been assessed for the management of horizontal defects But their results were mixed and sometimes disappointing The single flap approach SFA is a simplified minimally invasive surgical approach that enhances primary closure and minimizes tissue trauma The principle behind using this approach is that elevation of the limited mucoperiosteal flap allows surgical access from either the buccal or palatallingual aspect only depending on the extension of the lesion leaving the interdental supracrestal gingival tissue intact Main advantages associated with this approach that flap repositioning and suturing to the undetached papilla thereby preventing contamination by blood clots and reduction in post-surgical reduction Due to the emergence of biologic approach and biomaterials there is improved concern toward of horizontal defects Various factors determine the outcomes like patient-related factors site-related and clinician related factors Laser technology now a days becoming popular in various medical applications like photodynamic therapy Low level laser therapy LLLT also called photo-biomodulation enhance wound healing based on the principle of biomodulatory capacity of laser on body cells leading to increased cell activity12 It reduces excessive post-operative inflammation edema and pain LLLT can promote bone regeneration by enhancing proliferation and differentiation of human osteoblasts14 According to Gavish et al 780nm diode laser shown to inhibit the gene expression of pro-inflammatory cytokines interleukin-1 betaIL-1β modulate matrix metalloproteinase MMPs activity15 and reduce monocyte chemotactiprotein-1 MCP-1 IL-1α IL-10 and IL-6 in lipopolysaccharide-stimulated macrophages16 Numerous treatment approaches for restoring such defects have been investigated Despite laudable record autografts have been questioned for surgical invasiveness donor site morbidity limited quantity of donor material and increased operating time for harvesting procedures17 Limitations of the use of osteoinductive grafts is variation in bone induction capacity sourced from different tissue banks1819 When used in intrabony defects Enamel Matrix DerivativeEMD may restrict the space provision potential of the preparation20 Further application of EMD is a technique sensitive procedures and contamination of the material jeopardizing the regenerative potential The lack of rigidity and rapid degradation biodegradability make the use of PRF for periodontal regeneration difficult Nanocomposites and nanostructured materials are thought to have a key function in hard tissue research since natural bone tissue is a distinctive model of a nanocomposite Collagen has been potentially used in periodontal tissue engineering The integration of collagen as a structural protein serving as an essential component of connective tissue into three-dimensional scaffolds implanted after periodontal injury necrosis or inflammation has attracted much attention in tissue regeneration
According to Ibara et al scaffolds to be implanted are durable if composed of nanoparticles The nanoparticles facilitate healing process in contact with the tissues intended for the reformation Recently Thoma et al developed and tested collagen-based matrices as potential devices for soft tissue volume augmentation Volume stable collagen matrix VCMX is able to overcome the volume stability limitation of most commercially available grafts21 It is one of the most biocompatible novel material to be used in this study While mechanical stability is achieved by chemical crosslinking mechanical testing demonstrated preserved elasticity of the material over 14 days22 It has shown quite impressive results in resolving the intrabony defects in animal studies with an average of 5856 of new bone formation 23 Imber J-C et al23 preclinically evaluated the effect of a volume-stable collagen matrix on periodontal regeneration in two-wall intrabony defects This study provided histologic evidence for the potential of this novel VCMX to facilitate periodontal regeneration Asparuhova MB et al24 investigated the influence of a novel volume-stable collagen matrix VCMX on early wound healing events including cellular migration and adhesion protein adsorption and release and the dynamics of the hemostatic system Their study concluded that their data strongly support the effect of the novel VCMX on fibrin clot stabilization and coagulationfibrinolysis equilibrium thus facilitating progression to the next stages of the soft tissue healing process
Therefore the present study was planned to evaluate the supracrestal regenerative potential of volume stable collagen matrix VCMX along with single flap approachSFA when used with diode laser in the treatment of horizontal bone defect of stage 2 and 3 patients in comparison to OFD with diode laser and OFD alone
Methodology
Study design and settings The study design is Randomized controlled clinical trial and will be conducting in Department of Periodontology Post graduate Institute of Dental Sciences Rohtak Haryana
Study population
Systemically healthy patients with periodontitis stage 2 and stage 3 having horizontal bone loss will be enrolled in the present study
I Study conduct Patients will be enrolled according to inclusion and exclusion criteria from the outpatient department of periodontics Post Graduate Institute of Dental Sciences Rohtak Haryana Informed and written consent will be taken from each patient in his or her language
Randomization of patients would be done by generating the allocation sequence using computer-generated table by another investigator Patients will be randomly allocated into
Control group using single flap approach only
Test group 1 using collagen matrix and laser therapy in horizontal bone loss defects by single flap approach SFAVCMXLLLT
Test group 2 Single flap approach along with diode laser SFALLLT A balanced permuted block approach in blocks of four and six patients will be used to prepare the randomization tables After the debridement of the bone defect the eligibility of the bone defect would be confirmed Allocation concealment will be performed by opaque sealed envelopes that would be opened after debridement of horizontal bone loss defects and the surgeon will be informed of the allocated treatment Although the surgeon wont be blinded to the treatments the examiners recording clinical and radiographic parameters would be blind to the treatment groups Minimum One horizontal bone defect per patient will be included in the study
Periodontal parameters
Parameters recorded for experimental and adjacent teeth will include PIaque index PI and Gingival Index GI assessed at six surfaces mesiobuccal midbuccal distobuccal midlingualmidpalatal mesiolingual distolingual bleeding on probing BOP PPD CAL and gingival recession REC examined at six surfaces mesiobuccal midbuccal disto-buccal mesiolingualmesiopalatal midlingualmidpalatal distolingualdistopalatal
Radiographic Parameters that will be assessed using CBCT will include alveolar crest changes ACCOutcome measures will be revaluated at 3 6 9 months interval
Intervention
Presurgical patient preparation
Patients diagnosed with periodontitis who will meet the inclusion criteria will be screened for periodontal examination Based on this examination target sites will be identified Each patient will receive the initial phase of the therapy which will include oral hygiene instructions supragingival and subgingival debridement using ultrasonic Piezon EMS Dental Nyon Switzerland and hand instrumentations Gracey CurettesHu- Friedy Chicago IL USA and relieving of occlusal trauma
Surgical procedure
Surgical sites will be anaesthetized using local anaesthesia Simplified Papilla Preservation flap technique will be exercised using single flap approach Crevicular incisions will be made on buccallingualpalatal sites to raise a full-thickness mucoperiosteal flap Precaution would be taken to preserve the maximum interdental gingival tissue at the time of crevicular incision and no bone recontouring would be performed Thorough debridement of the surgical site would be performed For the test group1 VCMX would be placed according to the dimensions of the horizontal bone loss defect along with the use of diode laser LLLT on the inner epithelium of flap For the test group 2 SFA will be done along with the use of diode laser LLLT For control group SFA will be done And after this flap would be approximated and sutured at the original position with a monofilament suture material using interrupted sutures
Instructions for maintenance of proper oral hygiene will be reinforced Study participants will be scheduled for a follow-up visit weekly to1-month postsurgery and subsequently at 3- 6- and 9-month intervals
All statistical tests will use two-sided P values and statistical software will be used in the analysis of the study data Differences associated with P values 005 will be considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None