Clinical trial NCT06499155: Comparison of Cyanoacrylate Tissue Adhesive With Suture in the Treatment of Gingival Recession
Official title: Comparison of the Clinical Efficacy of Cyanoacrylate Tissue Adhesive With Suture in the Treatment of Gingival Recession
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gingival Recession
Keywords: connective tissue graft
coronally advanced flap
periacryl
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Eligibility criteria: Inclusion Criteria:

* Volunteers between the ages of 18-65
* 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

Exclusion Criteria:

* Not to be in inclusion criteria

Primary outcomes:
measure: Evaluation of the effect of periacryl on wound healing in the donor area with a visual analog scale
timeFrame: 6 months
measure: Determining the effect of periacryl on the root surface closure rate in the recipient area by proportioning the amount of root closure to the initial recession amount.
timeFrame: 6 months
measure: The effect of periacryl on the tissue thickness obtained after the procedure in the recipient area
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Necmettin Erbakan University
name: KEVSER YILDIRIM, RA
role: PRINCIPAL_INVESTIGATOR
References: