Dimensional Changes of the Keratinized Mucosa in Edentulous Ridges Following Accordian Technique Versus Conventional Free Gingival Grafts

NCT07365865 | Active Not Recruiting

• 1 other identifier: FGG by Accordian technique
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Inadequacy of the attached keratinized tissue (\<2 mm) affects the long-term maintenance of prostheses and implants due to poor oral hygiene, plaque accumulation, inflammation, bleeding on probing, gingival recession , attachment loss, and crestal bone loss .Consequently, keratinized tissue augmentation is considered to compensate for keratinized attached gingival width inadequacy. Lack of keratinized tissue (KT) or KT with a narrow width (≤2 mm) compromise the long-term maintenance of peri-implant tissue health . Peri-implantitis was more frequently detected at dental implants sites with reduced width of KT than at those with adequate KT width. Free gingival graft (FGG) is regarded as an efficient method with significant clinical application . However, following harvesting larger grafts, some limitations arise in the donor site. Extensive palatal wound may cause discomfort and morbidity for the patient, the rugae area is unsuitable for graft material and the greater palatine artery will be of a great concern.

Conditions

Healthy; Deficient Keratinized Mucosa

Keywords

free gingival graft; Accordian; keratinized mucosa

Outcome Measures

Primary Outcomes (1)

• Vertical graft shrinkage %

  Vertical graft shrinkage will be measured using UNC 15 Periodontal probe from reference point that will be taken (mid of the ridge) from where the graft will be sutured 3 months post-surgery

  Baseline 3 months

Secondary Outcomes (5)

• Apico coronal keratinized tissue width

  Baseline 3 months

• Vestibular depth

  Baseline 3 months

• Keratinized tissue thickness

  Baseline 3 months

• Post surgical pain assessment

  Day 1 Day 3 Day 14

• Patient satisfaction

  3 months

Study Arms (2)

Interventional group ( Accordian Group )

EXPERIMENTAL

steps from 1-7 as Active comparator group + 7 -Free gingival graft will be harvested from the palatal area, as previously mentioned, with a length of 40% of the mesiodistal length of the recipient area. Intermittent incisions to cover the whole length of the recipient area. 8- The graft will be located at the recipient area, and sutured with interrupted sutures.

Procedure: Expanded mesh free gingival graft ( Accordian technique )

Conventional free gingival graft

ACTIVE COMPARATOR

1- Infiltration anesthesia at the recipient area. 2- A horizontal incision, 0.5mm above the mucogingival junction extending along the area of the missing teeth. 3-Two vertical incisions diverging slightly in a corono-apical direction and extending into the alveolar mucosa. 4-The trapezoidal area will be dissected split thickness to expose the periosteum. 5-Infiltration anesthesia at the palatal area. 6-The free gingival graft will be harvested from the palate consisting of epithelial connective tissue of thickness more than 1mm.7- The palatal graft thickness will be determined by the coronal horizontal incision and the releasing incisions. The blade will be inserted perpendicular to the underlying deep tissue layers to a depth equal to the required graft thickness. 8- The graft will be harvested by inclining the blade horizontally, keeping it parallel to the external mucosal plane.9- The graft will be located at the recipient area, and sutured with interrupted sutures.

Procedure: conventional free gingival graft

Interventions

Expanded mesh free gingival graft ( Accordian technique ) PROCEDURE

Free gingival graft by expanded free gingival graft

Interventional group ( Accordian Group )

conventional free gingival graft PROCEDURE

conventional free gingival graft

Conventional free gingival graft

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with apico-coronal keratinized tissue width less than 2 millimeters
• Edentulous area with at least 2 missing teeth
• No systemic disease or active periodontitis
• Non smoker
• Age ≥ 20 years old .
• Plaque index and bleeding index \< 25%.
• Teeth loss with medium to thick gingival biotype (Periodontal probe not visible when inserted into the buccal gingival margin).
• Fully autonomous behavior and expression ability with good compliance.

You may not qualify if:

• Patients with any systemic disease
• Patients with symptoms such as inflammation, bleeding on probing, or pus discharge.
• Poor oral hygiene
• Adjacent teeth with acute and chronic tooth disease at the implant site
• Smokers ≥ 10 cigarettes/day.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo university

Cairo, Egypt

Location

Study Design

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

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: January 26, 2026
• Study Start: August 14, 2024
• Primary Completion: January 30, 2026
• Study Completion: March 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

EG (1)