Comparison of Cyanoacrylate Tissue Adhesive With Suture in the Treatment of Gingival Recession

NCT06499155 | Not Yet Recruiting FDA Device

• 1 other identifier: periacrylinCTG
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gingival Recession

Keywords

connective tissue graft; coronally advanced flap; periacryl

Outcome Measures

Primary Outcomes (3)

• Evaluation of the effect of periacryl on wound healing in the donor area with a visual analog scale

  In clinical follow-ups of gingival recession closure procedures; Wound healing in the donor area will be monitored with the help of a visual analog scale filled in by the patient.

  6 months

• 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.

  In clinical follow-ups of gingival recession closure procedures; Root surface closure rate in the recipient area; After the procedure, the amount of closure obtained in millimeters is divided by the initial amount of gingival recession to obtain a percentage value. Using these data, the effect of periacryl on the root surface closure rate will be determined.

  6 months

• The effect of periacryl on the tissue thickness obtained after the procedure in the recipient area

  In clinical follow-ups of gingival recession closure procedures; The increase in keratinized tissue thickness obtained in the recipient area will be measured in millimeters using the who probe. The data obtained will be compared to the initial keratinized tissue thickness amounts. In this way, the effect of periacryl on the increase in keratinized tissue in the recipient area will be observed.

  6 months

Study Arms (2)

tissue adhesive group

ACTIVE COMPARATOR

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.

Device: Use of periacryl in gingival recession closure procedures; Procedure: Use of sutures in gingival recession closure procedures

suture group

ACTIVE COMPARATOR

The donor and recipient areas will be closed with sutures.

Device: Use of periacryl in gingival recession closure procedures; Procedure: Use of sutures in gingival recession closure procedures

Interventions

Use of periacryl in gingival recession closure procedures DEVICE

Unlike the traditional procedure, periacryl tissue adhesive will be used in both the recipient and donor areas.

suture group; tissue adhesive group

Use of sutures in gingival recession closure procedures PROCEDURE

Both recipient and donor areas will be closed with traditional suturing techniques.

suture group; tissue adhesive group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Necmettin Erbakan University: lead

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• KEVSER YILDIRIM, RA

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

KEVSER YILDIRIM, RA

CONTACT

05385068995; kevseryildirim1996@hotmail.com

ZEYNEP TAŞTAN EROĞLU, Asst Prof.

CONTACT

05065857095; dt.zeyneptastan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: July 12, 2024
• Study Start: July 15, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 30, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07