Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06591156
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Gingival Recessions Treated by CAF with or Without PRF
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Treatment of Miller Class I Gingival Recessions by CAF with or Without Platelet-Rich Fibrin a Randomized Clinical Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GR with PRF
Brief Summary:
The objective of this study was to compare the efficacy of Coronal Advanced Flap CAF alone versus CAF combined with Leukocyte-Platelet-Rich Fibrin L-PRF to achieve root coverage in patients with gingival recession This was assessed by measuring the percentage of root coverage at six months post-surgery By focusing on the root coverage level the study aimed to determine whether adding L-PRF to CAF significantly improved over using CAF alone
The other objective was to provide a comprehensive assessment of the outcomes related to root coverage and overall patient satisfaction Moreover different outcomes of recession coverage were assessed including the percentage of complete root coverage and mean root coverage These evaluations were intended to offer a more detailed understanding of the possible success of each surgical technique Additionally the difference in gingival tissue thickness between the two groups was attempted to measure at six months post-surgery to determine whether the addition of L-PRF to CAF improved tissue quality and stability
The study also aimed to determine the overall volume gain in gingival tissue in the specific area of recession covered by both techniques providing information on their regenerative capabilities and the three-dimensional changes in tissue structure
Furthermore it sought to analyze the healing and recovery processes by comparing postoperative complications patient discomfort and overall recovery time between the two groups Finally another goal was to investigate the patientamp39s satisfaction with the aesthetic and functional outcomes of the procedures evaluating their perceptions of the success of treatment and the quality of life after surgery This comprehensive approach was designed to ensure that all relevant outcomes were considered offering a robust evaluation of the effectiveness and benefits of combining CAF with L-PRF and providing comparability with previous and future studies
The positive hypothesis raised was CAF combined with L-PRF will a result in significantly greater root coverage compared to CAF alone at six months post-surgery b lead to thicker gingival tissue and better tissue quality compared to CAF alone c will have a faster healing and recovery with fewer complications in the CAF with L-PRF group compared to the CAF alone group d will report higher satisfaction levels with the treatment outcomes compared to those undergoing CAF alone
The other objective was to provide a comprehensive assessment of the outcomes related to root coverage and overall patient satisfaction Moreover different outcomes of recession coverage were assessed including the percentage of complete root coverage and mean root coverage These evaluations were intended to offer a more detailed understanding of the possible success of each surgical technique Additionally the difference in gingival tissue thickness between the two groups was attempted to measure at six months post-surgery to determine whether the addition of L-PRF to CAF improved tissue quality and stability
The study also aimed to determine the overall volume gain in gingival tissue in the specific area of recession covered by both techniques providing information on their regenerative capabilities and the three-dimensional changes in tissue structure
Furthermore it sought to analyze the healing and recovery processes by comparing postoperative complications patient discomfort and overall recovery time between the two groups Finally another goal was to investigate the patientamp39s satisfaction with the aesthetic and functional outcomes of the procedures evaluating their perceptions of the success of treatment and the quality of life after surgery This comprehensive approach was designed to ensure that all relevant outcomes were considered offering a robust evaluation of the effectiveness and benefits of combining CAF with L-PRF and providing comparability with previous and future studies
The positive hypothesis raised was CAF combined with L-PRF will a result in significantly greater root coverage compared to CAF alone at six months post-surgery b lead to thicker gingival tissue and better tissue quality compared to CAF alone c will have a faster healing and recovery with fewer complications in the CAF with L-PRF group compared to the CAF alone group d will report higher satisfaction levels with the treatment outcomes compared to those undergoing CAF alone
Detailed Description:
A clinician not involved with the care of participants assessed eligibility and filled out the data form and after receiving the allocation information from the randomization unit the surgeon a clinician not involved in data collection started the protocolized procedure
BLOOD COLLECTION If a patient was assigned to the test group L-PRF a designed nurse proceeded to the blood collection to obtain L-PRF A vein basilica cephalic or median usually on the inside of the elbow or the back of the hand was the source of blood The area where the puncture occurred was cleaned with an antiseptic An elastic band or pressure cuff was wrapped around the forearm to squeeze the vein and make it more noticeable under the band This helped the needle find the vein more easily
As soon as that was done a needle was placed in the vein and blood was collected in a clean and sealed plastic tube Intra Spin - Intra-Lock between 4 and 6 tubes without anticoagulant During the process the band was removed to allow blood to flow normally and after the blood was collected the needle was removed and the puncture site was covered to prevent bleeding The L-PRF membranes were prepared according to the technique described by Choukroun et al 2001 Tubes were centrifuged immediately at 2700 rpm for 12 minutes on the centrifugation machine Intraspin Intra-lock Florida USA
After centrifugation the gelatinous portion obtained from each tube was removed and separated from the red part with tweezers The membranes obtained were placed on a sterile metal surface
The light metal plate and cover of the compression box eg Xpression Intra-Lock Boca Raton FL USA were used to gently compress the L-PRF clots by gravity After five minutes the L-PRF membranes could be used
A protocol of 2700RPM for 12 minutes RCF-clot 408g was used to produce L-PRF membranes with leukocytes and platelets L-PRF membranes were produced utilizing an Intraspin centrifugation device 33 rotor angulation 50mm radius at the clot 80mm at the max Intra-Lock Boca Raton Florida USA utilizing 9mL glass-coated plastic tubes Intra-Lock
SURGICAL PROCEDURE In case of CEJ undetectable or with 39step39 CEJ restoration was performed prior to the surgical procedure and digital scan T0
The coronally advanced flap CAF technique for multiple gingival recessions as described by de Sanctis and Zucchelli is a minimally invasive surgical procedure with intrasulcular incisions around the affected teeth and horizontal incisions in the interdental areas preserving the papillae A split-full-split thickness envelope flap is then elevated with split-thickness dissection in the papillae and beyond the mucogingival junction and full-thickness at the recession level This technique avoids vertical releasing incisions contributing to better blood supply improved esthetics and a more comfortable postoperative experience for the patient
SURGICAL STEP BY STEP The anesthetic was applied to the intervened area and a coronal advance flap was created After local anesthesia a horizontal incision was made delimitating the coronal part of the flap This horizontal incision of the envelope flap consists of an oblique submarginal incision in the interdental areas that creates a surgical papilla The incisions continue with the intrasulcular incision in the recession defects and are extended to form an envelope flap between the central and molar This design facilitates the planned coronal repositioning of the flap tissue on the exposed root surfaces
The envelope flap is raised with a split-full-split approach in the coronal-apical direction and the oblique interdental incisions are performed keeping the blade parallel to the long axis of the teeth to dissect the surgical papilla in a split-thickness manner
The apical gingival tissue at root exposures is raised to a full thickness to provide the critical part of the flap for root coverage with more thickness Finally the most apical portion of the flap is elevated in a split-thickness to facilitate coronal displacement of the flap At the limit of the flap central and molar a hemi-utilization was performed to ensure the release of tension and better mobilization of the flap at extremities
Then a sharp dissection was performed in the mucosa of the vestibular lining to eliminate muscle tension It must be considered that the 34adequate34 coronal displacement of the flap results from eliminating muscle and lip tensions in the apical part of the flap This way the flap design incorporates a wide base to ensure adequate blood supply with the base of the flap being wider than the coronal portion to promote better vascularization and healing The flaps length should be sufficient to cover the recession defects fully and extend coronally beyond the CEJ of the involved teeth ensuring complete coverage of the exposed roots and promoting optimal healing
The epithelium is removed from the anatomical papillae to allow them to fit the surgical papillae at the time of suture Then root cleaning is performed with manual Mini-Gracey curettes LM Finland
In the CAFL-PRF group ideal 6 minimum 4 L-PRF membranes with dimensions of receptor bed are fixed together with resorbable suture six zeros Novosyn BBraun Melsungen Germany and adapted to the root surface at CEJ level with the face of the inner membrane towards the recession
The flap is then repositioned Each surgical papilla that was dislocated surgically concerning the anatomic papilla by the oblique submarginal interdental incisions is now placed over the de-epithelialized papilla promoting a rotation of the flap toward the canine and in a coronal direction One of the key factors for recession coverage techniques is ensuring that the flap can be advanced coronally without any tension So if considered necessary when verifying the reposition of the flap additional partial-thickness dissection was performed apically to relieve tension and allow for proper positioning of the flap before suture
After repositioning the flap it was stabilized with a suspended suture Sling sutures with 60 PTFE Elasyn BBraun Melsungen Germany were used to precisely adapt the buccal flap on the exposed root surfaces and stabilize every surgical papilla
To ensure standardization of the technique and less variability the flap was always performed from central to first molar no vertical incisions even if there was no recession at the lateral or central level
BLOOD COLLECTION If a patient was assigned to the test group L-PRF a designed nurse proceeded to the blood collection to obtain L-PRF A vein basilica cephalic or median usually on the inside of the elbow or the back of the hand was the source of blood The area where the puncture occurred was cleaned with an antiseptic An elastic band or pressure cuff was wrapped around the forearm to squeeze the vein and make it more noticeable under the band This helped the needle find the vein more easily
As soon as that was done a needle was placed in the vein and blood was collected in a clean and sealed plastic tube Intra Spin - Intra-Lock between 4 and 6 tubes without anticoagulant During the process the band was removed to allow blood to flow normally and after the blood was collected the needle was removed and the puncture site was covered to prevent bleeding The L-PRF membranes were prepared according to the technique described by Choukroun et al 2001 Tubes were centrifuged immediately at 2700 rpm for 12 minutes on the centrifugation machine Intraspin Intra-lock Florida USA
After centrifugation the gelatinous portion obtained from each tube was removed and separated from the red part with tweezers The membranes obtained were placed on a sterile metal surface
The light metal plate and cover of the compression box eg Xpression Intra-Lock Boca Raton FL USA were used to gently compress the L-PRF clots by gravity After five minutes the L-PRF membranes could be used
A protocol of 2700RPM for 12 minutes RCF-clot 408g was used to produce L-PRF membranes with leukocytes and platelets L-PRF membranes were produced utilizing an Intraspin centrifugation device 33 rotor angulation 50mm radius at the clot 80mm at the max Intra-Lock Boca Raton Florida USA utilizing 9mL glass-coated plastic tubes Intra-Lock
SURGICAL PROCEDURE In case of CEJ undetectable or with 39step39 CEJ restoration was performed prior to the surgical procedure and digital scan T0
The coronally advanced flap CAF technique for multiple gingival recessions as described by de Sanctis and Zucchelli is a minimally invasive surgical procedure with intrasulcular incisions around the affected teeth and horizontal incisions in the interdental areas preserving the papillae A split-full-split thickness envelope flap is then elevated with split-thickness dissection in the papillae and beyond the mucogingival junction and full-thickness at the recession level This technique avoids vertical releasing incisions contributing to better blood supply improved esthetics and a more comfortable postoperative experience for the patient
SURGICAL STEP BY STEP The anesthetic was applied to the intervened area and a coronal advance flap was created After local anesthesia a horizontal incision was made delimitating the coronal part of the flap This horizontal incision of the envelope flap consists of an oblique submarginal incision in the interdental areas that creates a surgical papilla The incisions continue with the intrasulcular incision in the recession defects and are extended to form an envelope flap between the central and molar This design facilitates the planned coronal repositioning of the flap tissue on the exposed root surfaces
The envelope flap is raised with a split-full-split approach in the coronal-apical direction and the oblique interdental incisions are performed keeping the blade parallel to the long axis of the teeth to dissect the surgical papilla in a split-thickness manner
The apical gingival tissue at root exposures is raised to a full thickness to provide the critical part of the flap for root coverage with more thickness Finally the most apical portion of the flap is elevated in a split-thickness to facilitate coronal displacement of the flap At the limit of the flap central and molar a hemi-utilization was performed to ensure the release of tension and better mobilization of the flap at extremities
Then a sharp dissection was performed in the mucosa of the vestibular lining to eliminate muscle tension It must be considered that the 34adequate34 coronal displacement of the flap results from eliminating muscle and lip tensions in the apical part of the flap This way the flap design incorporates a wide base to ensure adequate blood supply with the base of the flap being wider than the coronal portion to promote better vascularization and healing The flaps length should be sufficient to cover the recession defects fully and extend coronally beyond the CEJ of the involved teeth ensuring complete coverage of the exposed roots and promoting optimal healing
The epithelium is removed from the anatomical papillae to allow them to fit the surgical papillae at the time of suture Then root cleaning is performed with manual Mini-Gracey curettes LM Finland
In the CAFL-PRF group ideal 6 minimum 4 L-PRF membranes with dimensions of receptor bed are fixed together with resorbable suture six zeros Novosyn BBraun Melsungen Germany and adapted to the root surface at CEJ level with the face of the inner membrane towards the recession
The flap is then repositioned Each surgical papilla that was dislocated surgically concerning the anatomic papilla by the oblique submarginal interdental incisions is now placed over the de-epithelialized papilla promoting a rotation of the flap toward the canine and in a coronal direction One of the key factors for recession coverage techniques is ensuring that the flap can be advanced coronally without any tension So if considered necessary when verifying the reposition of the flap additional partial-thickness dissection was performed apically to relieve tension and allow for proper positioning of the flap before suture
After repositioning the flap it was stabilized with a suspended suture Sling sutures with 60 PTFE Elasyn BBraun Melsungen Germany were used to precisely adapt the buccal flap on the exposed root surfaces and stabilize every surgical papilla
To ensure standardization of the technique and less variability the flap was always performed from central to first molar no vertical incisions even if there was no recession at the lateral or central level
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None