Effect of Modified Free Gingival Graft and Conventional Free Gingival Graft on Gingival Recession

NCT06737120 | Not Yet Recruiting

• 1 other identifier: ModifiedFreeGingivalGraft
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical study is to understand whether the modified free gingival graft technique is superior to the conventional free gingival graft: Will gingival recession completely close in modified free gingival grafting areas? Will there be a significant increase in the amount of keratinized gingiva in modified free gingival grafting participants compared to traditional free gingival grafting participants? Participants will visit our clinic in the 1st, 3rd and 6th months. Necessary clinical parameter measurements will be made by the clinician.

Conditions

Gingival Recession, Localized; Keratinized Tissue; Free Gingival Graft

Keywords

modified free gingival graft; free gingival graft; gingival recession

Outcome Measures

Primary Outcomes (4)

• measurement of preoperative periodontal parameters

  To determine the baseline condition, preoperative measurement of periodontal parameters (amount of keratinized tissue, papilla height, papilla width, probing pocket depth, amount of recession, tissue thickness) will be recorded in millimeters using a periodontal probe.

  Preoperatively, before the start of treatment.

• Preoperative Intraoral Photographs Capture and Evaluation

  Intraoral photographs of patients will be taken before surgery. These photographs will be used to meet the situation before and after treatment. The photographs will be taken with a high-performance digital camera under standardized angles and lighting. Unit of Measurement: General condition of oral structures (% change rate).

  Preoperatively, before the start of treatment.

• gingival index measurement

  The status of gingival health will be assessed using the Gingival Index (Loe and Silness, 1963). This measurement will be made to determine the degree of gingival inflammation and will be scored on a scale from 0 (healthy gingiva) to 3 (severe inflammation and bleeding). Unit of Measurement: 0-3 scale.

  Preoperatively, before the start of treatment.

• Plaque Index (PI) measurement

  The degree of plaque accumulation on the tooth surfaces will be assessed using the Plaque Index (Silness and Loe, 1964). The assessment will be made on a scale from 0 (no plaque) to 3 (entire tooth surface covered with plaque). This measurement will be used to objectively determine the degree of plaque formation.Unit of Measurement: 0-3 scale.

  Preoperatively, before the start of treatment.

Secondary Outcomes (4)

• Measurement of Periodontal Parameters

  1,3 and 6 months post-operation.

• Post-Operative Photographing and Evaluation

  1,3 and 6 months post-operation.

• gingival index measurement

  1,3 and 6 months post-operation.

• Plaque Index (PI) measurement

  1,3 and 6 months post-operation.

Study Arms (2)

modified free gingival graft

EXPERIMENTAL

A connective tissue pedicle flap will be applied before a free gingival graft is placed in the recipient area.

Procedure: Mod-fgg

traditional free gingival graft

EXPERIMENTAL

Procedure: Fgg

Interventions

Mod-fgg PROCEDURE

Following an intrasulcular incision, 2 mm long horizontal incisions will be made on each side at the level of the gum line. From these incisions, divergent vertical release incisions will be made extending towards the alveolar mucosa. To prepare the recipient area, a thin partial thickness flap will be lifted and then removed. A foil template will be obtained by measuring the dimensions of the resulting area. A horizontal incision will be made apical to the exposed root area of the target teeth at a distance corresponding to the height of the exposed root surface. Starting from the endpoints of this incision, two more slightly divergent incisions will be made in the coronal direction. Thus, a connective tissue pedicle flap will be formed and carefully separated from the periosteum. The pedicle graft will be turned over the exposed root surface and fixed with bioabsorbable sutures. The palatal graft will be sutured to cover the connective tissue.

modified free gingival graft

Fgg PROCEDURE

The surgical procedures to be performed in this group will be the same as in the modified free gingival graft group, but no connective tissue pedicle flap will be performed.

traditional free gingival graft

Eligibility Criteria

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

You may qualify if:

• To be systemically healthy.
• Not smoking.
• Individuals aged 18 years and over.
• Shallow vestibule (≤5 mm).
• The periodontal pocket depth of the tooth/teeth to be treated should be ≤3 mm and the degree of tooth mobility should be ≤1.
• There should be no cervical composite restoration and no caries-free lesions on the teeth to be treated.
• Presence of Cairo Type 1 class gingival recession on the buccal surface of at most 2 of the mandibular incisors.

You may not qualify if:

• pregnancy
• untreated periodontal disease
• parafunctional habits
• poor oral hygiene (persistent whole mouth plaque index \> 20%)
• iodine allergy
• excessive dental crowding or misalignment of teeth.

Sponsors & Collaborators

• AYSE HUMEYRA ORUC: lead

Study Sites (1)

Necmettin Erbakan University

Konya, Turkey (Türkiye)

Location

Related Publications (2)

• Camargo PM, Melnick PR, Kenney EB. The use of free gingival grafts for aesthetic purposes. Periodontol 2000. 2001;27:72-96. doi: 10.1034/j.1600-0757.2001.027001072.x. No abstract available.

  PMID: 11551301 BACKGROUND

• Carcuac O, Trullenque-Eriksson A, Derks J. Modified free gingival graft technique for treatment of gingival recession defects at mandibular incisors: A randomized clinical trial. J Periodontol. 2023 Jun;94(6):722-730. doi: 10.1002/JPER.22-0581. Epub 2023 Jan 30.

  PMID: 36627509 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Interventions

fibrinopeptides gamma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

ayşe hümeyra oruç

CONTACT

+90 0332 220 00 26; ayse61836@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 17, 2024
• Study Start: December 30, 2024
• Primary Completion: March 30, 2025
• Study Completion: July 30, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)