Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries

NCT ID: NCT05688293

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-05

Study Completion Date

2026-03-01

Brief Summary

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Thin gingival phenotype is one of the major causative factors of gingival recession type 1 which can result in hypersensitivity, discomfort, and compromised esthetics. This study assess the efficacy of increasing the gingival thickness from thin gingival phenotype to thick gingival phenotype in the treatment of patients suffering from gingival recession (RT1) and maintenance of results using either connective tissue graft or de-epithelized free gingival graft after non-surgical periodontal debridement compared to non-surgical periodontal debridement alone.

Detailed Description

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This parallel arm randomized controlled clinical trial study will include systematically free patients with thin gingival phenotype. They will be randomly allocated to three equal groups. Group A (test group, n=10) will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique, Group B (test group, n=10) will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft, while group C (control group, n=10) will receive non-surgical periodontal treatment only. After 3, 6 and 12 months gingival biotype will be clinically assessed (1ry outcome). This parameter will be recorded at baseline, 3, 6 and 12 months. The 2ry outcomes will include recording of recession depth, plaque index, bleeding on probing, keratinized tissue width . Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post-surgically. Postoperative instructions and medication will be given to the patient. All readings will be carried out by a calibrated outcome assessor who will be masked. Follow-up will be performed to assess the outcomes and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.

Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three parallel groups
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
the patient won't know the type of the procedures done to him The outcome assessor won't know which group he the is assessing it's results

Study Groups

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Connective tissue graft

Patients will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique

Group Type ACTIVE_COMPARATOR

Connective tissue graft

Intervention Type PROCEDURE

non-surgical periodontal treatment and connective tissue graft

Free gingival Graft

Patients will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft

Group Type ACTIVE_COMPARATOR

Free gingival graft

Intervention Type PROCEDURE

will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft

Non surgical procedure

Patients will receive non-surgical periodontal treatment only

Group Type ACTIVE_COMPARATOR

Non surgical

Intervention Type PROCEDURE

non-surgical periodontal treatment only

Interventions

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Connective tissue graft

non-surgical periodontal treatment and connective tissue graft

Intervention Type PROCEDURE

Free gingival graft

will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft

Intervention Type PROCEDURE

Non surgical

non-surgical periodontal treatment only

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Medically free patients (American Society of Anesthesiologists I; ASA I)
* Patients diagnosed with recession (RT1)
* Fair oral hygiene
* Patient accepting to provides an informed consent and the follow-up

Exclusion Criteria

* Carious teeth and teeth with periapical infection.
* Patients diagnosed with periodontitis
* Smokers
* Pregnant and lactating females
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Misr International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zainab Hafez, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Lecturer, faculty of oral and dental medicine misr international university

Shahinaz Al ashiry, Asso. Prof

Role: STUDY_DIRECTOR

Associate professor, faculty of oral and dental medicine misr international university

Yahia Amer, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Lecturer, faculty of oral and dental medicine misr international universit

Locations

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Faculty of oral and dental medicine, Misr international university

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Zainab Hafez, Lecturer

Role: CONTACT

+01221334637

Shahinaz Al ashiry, Asso. Prof

Role: CONTACT

Facility Contacts

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Zainab Hafez, Lecturer

Role: primary

Yahia amer, Lecturer

Role: backup

Other Identifiers

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PER 5213005

Identifier Type: -

Identifier Source: org_study_id

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