Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499155
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-03-28
Brief Title:
Comparison of Cyanoacrylate Tissue Adhesive With Suture in the Treatment of Gingival Recession
Sponsor:
Necmettin Erbakan University
Organization:
Necmettin Erbakan University
Study Overview
Official Title:
Comparison of the Clinical Efficacy of Cyanoacrylate Tissue Adhesive With Suture in the Treatment of Gingival Recession
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
The aim of this randomized controlled clinical study was to determine the effects of gingival recession closure procedures performed with tissue adhesive and suture on gingival thickness To evaluate the effect on the amount of gingival recession keratinized tissue amount clinical attachment level probing pocket depth papilla width and height root coverage rate wound healing visual analogue scale gingival index and plaque index
The main questions it aims to answer are
Does the use of tissue adhesive in gingival recession closure procedures affect tissue healing in the recipient area
Does the use of tissue adhesive in gingival recession closure procedures affect tissue healing in the donor area Participants will be informed about the study and the procedures to be performed and the patients will continue their routine follow-up
The main questions it aims to answer are
Does the use of tissue adhesive in gingival recession closure procedures affect tissue healing in the recipient area
Does the use of tissue adhesive in gingival recession closure procedures affect tissue healing in the donor area Participants will be informed about the study and the procedures to be performed and the patients will continue their routine follow-up
Detailed Description:
Gingival recession is known as the apical displacement of the gum from the cement-enamel junction Various root coverage procedures have been successfully performed to prevent recession correct aesthetic problems help control plaque and reduce dentin hypersensitivity
The ultimate goal of the root coverage procedure is to prevent correct or eliminate the recession defect with an appearance compatible with the adjacent soft tissues following healing and with minimal probing depth
The aim of this study is to evaluate the clinical effectiveness of fixing the donor area with periacryl tissue adhesive instead of suture and supporting the sutures placed on the flap in the recipient area with periacryl tissue adhesive in modified coronally placed flap operations performed in combination with subepithelial connective tissue graft in patients with Miller class I and II gingival recession to evaluate and compare with the classical technique using only sutures
This study is planned to be conducted on 40 individuals aged between 18-65 Patients who do not have any systemic disease do not smoke or drink alcohol are not pregnant or breastfeeding have not used antibiotics in the last 6 months and do not use regular medication will be included in the study
In this study patients will be divided into 2 groups according to whether they use periacryl or not
This study is planned prospectively and the initial 1st 3rd 6th and 12th month follow-up measurements of the patients who will be treated in our clinic will be evaluated In the measurements gingival recession parameters including probing depth clinical attachment level and recession depth keratinized tissue width and gingival thickness will be evaluated In multiple gingival recessions plaque index and gingival index will be obtained from three points mesial distal and midpoints The plaque index will be calculated according to the criteria determined by Silness and Loe while the gingival index will be calculated according to the criteria determined by Loe and Silness
On postoperative days 1 3 and 7 patients will be asked to fill out a table in which they can score their subjective complaints of pain burning sensation and discomfort in the surgical area on a personal pain scale VAS ranging from 0 not at all to 100 very severe
In this study the physician When removing stitches 2 weeks after surgery the wound healing index will be filled in for each tooth individually evaluated according to Huangs criteria
In this randomized controlled clinical study it was determined in which of 40 patients periacryl tissue adhesive would be used and in which suture It will be determined by computer-assisted randomization method wwwrandomizerorg All surgical procedures and measurements will be performed by the same clinician
The primary endpoint was 6-month clinical follow-up of gingival recession closure procedures The aim is to determine the effect on wound healing and tissue thickness in the donor area and on the root surface coverage rate and tissue thickness in the recipient area
surgical procedure Root surfaces in gingival recession areas will be smoothed using Gracey curettes
Submarginal incisions will be made in the interdental areas and intrasulcular incisions will be made around the teeth with recession defects Half-full-half thickness flap incisions will be applied in the corona-apical direction
No vertical relaxing incision will be made and the papilla adjacent to the relevant tooth will be de-epithelialised to create a connective tissue bed In surgical areas the previously prepared subepithelial connective tissue graft will be fixed to the periosteum using 5-0 resorbable suture The flap will be designed to be relieved by an incision of the periosteum and positioned coronally without tension The area will be closed with 5-0 non-resorbable stitches and hemostasis will be achieved by applying light finger pressure for 4 minutes Sutures will be supported with periacryl tissue adhesive in half of the patients
The palatal donor area will be measured with a periodontal probe to ensure that the soft tissue thickness is at least 3 mm and a parallel incision will be made in the donor area usually in the palatal area between the maxillary first molar and the maxillary canine staying at least 2 mm away from the tooth edge A vertical relaxing incision will be applied to remove the subepithelial connective tissue graft from the palate The palate will be sutured with 4-0 absorbable suture or secured with periacryl tissue adhesive Before the connective tissue is placed in the recipient area the fatty and secretory tissue and the band-shaped epithelium overlying the connective tissue will be removed using scissors
Stitches will be removed 14 days after surgery Interdental care will begin approximately 2 weeks after the stitches are removed patients will be asked to come for routine control visits 1 3 6 months after the surgery and clinical measurements andor photographs will be taken during the control visits
The ultimate goal of the root coverage procedure is to prevent correct or eliminate the recession defect with an appearance compatible with the adjacent soft tissues following healing and with minimal probing depth
The aim of this study is to evaluate the clinical effectiveness of fixing the donor area with periacryl tissue adhesive instead of suture and supporting the sutures placed on the flap in the recipient area with periacryl tissue adhesive in modified coronally placed flap operations performed in combination with subepithelial connective tissue graft in patients with Miller class I and II gingival recession to evaluate and compare with the classical technique using only sutures
This study is planned to be conducted on 40 individuals aged between 18-65 Patients who do not have any systemic disease do not smoke or drink alcohol are not pregnant or breastfeeding have not used antibiotics in the last 6 months and do not use regular medication will be included in the study
In this study patients will be divided into 2 groups according to whether they use periacryl or not
This study is planned prospectively and the initial 1st 3rd 6th and 12th month follow-up measurements of the patients who will be treated in our clinic will be evaluated In the measurements gingival recession parameters including probing depth clinical attachment level and recession depth keratinized tissue width and gingival thickness will be evaluated In multiple gingival recessions plaque index and gingival index will be obtained from three points mesial distal and midpoints The plaque index will be calculated according to the criteria determined by Silness and Loe while the gingival index will be calculated according to the criteria determined by Loe and Silness
On postoperative days 1 3 and 7 patients will be asked to fill out a table in which they can score their subjective complaints of pain burning sensation and discomfort in the surgical area on a personal pain scale VAS ranging from 0 not at all to 100 very severe
In this study the physician When removing stitches 2 weeks after surgery the wound healing index will be filled in for each tooth individually evaluated according to Huangs criteria
In this randomized controlled clinical study it was determined in which of 40 patients periacryl tissue adhesive would be used and in which suture It will be determined by computer-assisted randomization method wwwrandomizerorg All surgical procedures and measurements will be performed by the same clinician
The primary endpoint was 6-month clinical follow-up of gingival recession closure procedures The aim is to determine the effect on wound healing and tissue thickness in the donor area and on the root surface coverage rate and tissue thickness in the recipient area
surgical procedure Root surfaces in gingival recession areas will be smoothed using Gracey curettes
Submarginal incisions will be made in the interdental areas and intrasulcular incisions will be made around the teeth with recession defects Half-full-half thickness flap incisions will be applied in the corona-apical direction
No vertical relaxing incision will be made and the papilla adjacent to the relevant tooth will be de-epithelialised to create a connective tissue bed In surgical areas the previously prepared subepithelial connective tissue graft will be fixed to the periosteum using 5-0 resorbable suture The flap will be designed to be relieved by an incision of the periosteum and positioned coronally without tension The area will be closed with 5-0 non-resorbable stitches and hemostasis will be achieved by applying light finger pressure for 4 minutes Sutures will be supported with periacryl tissue adhesive in half of the patients
The palatal donor area will be measured with a periodontal probe to ensure that the soft tissue thickness is at least 3 mm and a parallel incision will be made in the donor area usually in the palatal area between the maxillary first molar and the maxillary canine staying at least 2 mm away from the tooth edge A vertical relaxing incision will be applied to remove the subepithelial connective tissue graft from the palate The palate will be sutured with 4-0 absorbable suture or secured with periacryl tissue adhesive Before the connective tissue is placed in the recipient area the fatty and secretory tissue and the band-shaped epithelium overlying the connective tissue will be removed using scissors
Stitches will be removed 14 days after surgery Interdental care will begin approximately 2 weeks after the stitches are removed patients will be asked to come for routine control visits 1 3 6 months after the surgery and clinical measurements andor photographs will be taken during the control visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None