NCT07854132

Brief Summary

The goal of this randomized clinical study is to compare in Adults Clinical Effect of Frenal Relocation without Free Gingival Graft Application on Keratinized Tissue Gain When Compared to Frenal Relocation with Free Gingival Graft Application. The main question aims to answer: In Adults with high frenum attachment, will frenal relocation alone show a difference or enhance the keratinized tissue gain compared to frenal relocation procedure combined with the application of a free gingival graft?

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Sep 2026Jun 2027

First Submitted

Initial submission to the registry

September 12, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

September 30, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

8 months

First QC Date

September 12, 2026

Last Update Submit

September 26, 2026

Conditions

Keratinized Tissue Gain

Keywords

FrenotomyFree Gingival GraftKeratinized Tissue Width

Outcome Measures

Primary Outcomes (1)

  • Keratinized tissue gain

    6 months

Secondary Outcomes (6)

  • Relapse Rate

    6 months

  • Post-operative Pain (Numerical Rating scale)

    1 week

  • Mucosal Scar Index

    6 months

  • Patient Satisfaction Questionnaire

    6 months

  • Gingival Index

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Frenotomy

EXPERIMENTAL

1. Two C-shaped partial thickness incisions will be placed on the two sides of the frenum leaving the underlying periosteum intact with a 15c# blade. 2. Relocation of the muscle attachment will be performed by blunt dissection using a mucoperiosteal elevator. 3. Undermining or separation of the epithelial boundaries from the underlying lip mucosa will then be performed by blunt dissection to facilitate tension-free suturing. 4. The epithelium will be sutured to the underlying periosteum using three interrupted periosteal 6-0 resorbable sutures and left to heal by secondary intention.

Procedure: Frenotomy

Frenotomy with Free Gingival Graft

ACTIVE COMPARATOR

1. Two C-shaped partial thickness incisions will be placed on the two sides of the frenum leaving the underlying periosteum intact with a 15c# blade. 2. Relocation of the muscle attachment will be performed by blunt dissection using a mucoperiosteal elevator. 3. Undermining or separation of the epithelial boundaries from the underlying lip mucosa will then be performed by blunt dissection to facilitate tension-free suturing. 4. The desired size of the graft will be determined using a template and a free gingival graft will be harvested from the palate. 5. The graft will then be positioned and adapted firmly by suturing to the periosteum at the recipient site using 6-0 resorbable sutures. 6. The epithelium will be then sutured to the underlying periosteum using three interrupted periosteal 6-0 sutures and left to heal by secondary intention.

Procedure: Frenotomy with Free Gingival Graft

Interventions

FrenotomyPROCEDURE

1. Two C-shaped partial thickness incisions will be placed on the two sides of the frenum leaving the underlying periosteum intact with a 15c# blade. 2. Relocation of the muscle attachment will be performed by blunt dissection using a mucoperiosteal elevator. 3. Undermining or separation of the epithelial boundaries from the underlying lip mucosa will then be performed by blunt dissection to facilitate tension-free suturing. 4. The epithelium will be sutured to the underlying periosteum using three interrupted periosteal 6-0 resorbable sutures and left to heal by secondary intention.

Also known as: Frenal Relocation, Frenulotomy
Frenotomy
Frenotomy with Free Gingival GraftPROCEDURE

1. Two C-shaped partial thickness incisions will be placed on the two sides of the frenum leaving the underlying periosteum intact with a 15c# blade. 2. Relocation of the muscle attachment will be performed by blunt dissection using a mucoperiosteal elevator. 3. Undermining or separation of the epithelial boundaries from the underlying lip mucosa will then be performed by blunt dissection to facilitate tension-free suturing. 4. The desired size of the graft will be determined using a template and a free gingival graft will be harvested from the palate. 5. The graft will then be positioned and adapted firmly by suturing to the periosteum at the recipient site using 6-0 resorbable sutures. 6. The epithelium will be then sutured to the underlying periosteum using three interrupted periosteal 6-0 sutures and left to heal by secondary intention.

Also known as: Frenum relocation with Free Gingival Graft, Frenotomy with FGG
Frenotomy with Free Gingival Graft

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Systemically healthy.
  • Good oral hygiene (Gingival and plaque index \<20%)
  • Highly attached labial frenum.
  • Narrow sulcus depth.
  • Current smokers who smoke ≤10 cigarettes per day

You may not qualify if:

  • Smokers who smoke \>10 cigarettes per day.
  • Poor oral hygiene.
  • Patient with a physical disability that hinders the upkeep of good oral hygiene measures.
  • Any systemic diseases or taking any medications that could affect wound healing.
  • Periodontitis patients.
  • Previous frenal procedures.
  • Pregnant or lactating females.
  • Pervious periodontal surgery within the last 6 months before the start of the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October University for Modern Sciences and Arts

Giza, Egypt

Location

Related Publications (34)

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    BACKGROUND

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MeSH Terms

Interventions

Oral Frenectomyfibrinopeptides gamma

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistry

Central Study Contacts

Abdelrahman M Mahrous, BDS

CONTACT

+2 01015577010abdelrahman.mohammed8@msa.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Randomization: Random sequence generation: Computer generated randomization (random.org) will be used for patient's division into two groups. Allocation concealment mechanism: Patients will be sequentially numbered, and a central telephone will be used to inform the operator of the allocation of the patients to either group after re-evaluation post no-surgical periodontal therapy is preformed and signed written consent is obtained.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparing the test group "frenotomy alone" with "frenotomy with FGG" the control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant

Study Record Dates

First Submitted

September 12, 2026

First Posted

October 2, 2026

Study Start

September 30, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

October 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access

Locations

EG(1)