Comparison of Cyanoacrylate Tissue Adhesive With Suture in the Treatment of Gingival Recession
NCT ID: NCT06499155
Last Updated: 2024-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2024-07-15
2024-12-30
Brief Summary
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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.
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Detailed Description
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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 Huang's 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 (www.randomizer.org). 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 and/or photographs will be taken during the control visits.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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tissue adhesive group
Only tissue adhesive will be used for primary closure of the donor area. After the flap is closed with sutures in the recipient area, it will be supported with tissue adhesive.
Use of periacryl in gingival recession closure procedures
Unlike the traditional procedure, periacryl tissue adhesive will be used in both the recipient and donor areas.
Use of sutures in gingival recession closure procedures
Both recipient and donor areas will be closed with traditional suturing techniques.
suture group
The donor and recipient areas will be closed with sutures.
Use of periacryl in gingival recession closure procedures
Unlike the traditional procedure, periacryl tissue adhesive will be used in both the recipient and donor areas.
Use of sutures in gingival recession closure procedures
Both recipient and donor areas will be closed with traditional suturing techniques.
Interventions
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Use of periacryl in gingival recession closure procedures
Unlike the traditional procedure, periacryl tissue adhesive will be used in both the recipient and donor areas.
Use of sutures in gingival recession closure procedures
Both recipient and donor areas will be closed with traditional suturing techniques.
Eligibility Criteria
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Inclusion Criteria
* Absence of any systemic disease such as endocrine disease, nephrotic syndrome, chronic renal disease and cardiovascular disease
* Not having uncontrolled diabetes mellitus with HbA1c\>7,
* Not smoking and not having any blood diseases,
* Not having used antibiotics in the last 6 months for any reason,
* There must be no previous surgical procedure in the selected areas.
* The presence of periodontal pockets not exceeding 3 mm in size on the treated teeth; No occlusal trauma to teeth
* Having at least 20 teeth in the mouth
* People who are not pregnant or breastfeeding and who are not taking any regulatory medication.
* Patients who applied to the periodontology clinic with various periodontal problems and received an indication for connective tissue graft operation due to receding gums
* There is no systemic condition that may prevent surgical application.
* Not using drugs systemically
18 Years
65 Years
ALL
Yes
Sponsors
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Necmettin Erbakan University
OTHER
Responsible Party
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Kevser Yildirim
Research Assistant
Principal Investigators
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KEVSER YILDIRIM, RA
Role: PRINCIPAL_INVESTIGATOR
Necmettin Erbakan University
Central Contacts
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Other Identifiers
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periacrylinCTG
Identifier Type: -
Identifier Source: org_study_id
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