Novel Soft Tissue Augmentation Technique Using Free Gingival Graft Simultaneous With Posterior Mandibular Implant

NCT ID: NCT06645925

Last Updated: 2026-01-29

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2027-12-30

Brief Summary

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Presence of keratinized tissue (KT) around dental implants, plays a crucial role in stability and health of peri-implant tissues. Several studies reported that, minimum of 2 mm keratinized tissue width is required to achieve long-term longevity. Insufficient keratinized mucosa leads to biofilm accumulation, soft tissue inflammation, eventually peri-implant mucositis and peri-implantitis. Hence, the aim of the present trial is to evaluate KTW gain, linear and volumetric changes in buccal soft tissue along with hard tissue alterations following implant restoration at sites treated either with delayed implant placement \& simultaneous FGG or the conventional FGG protocol prior to implant placement.

Detailed Description

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Conditions

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Free Gingival Graft Free Gingival Graft Volume Change Keratinized Tissue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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One Step Protocol

FGG simultaneous with delayed implant placement

Group Type EXPERIMENTAL

One Step Protocol

Intervention Type PROCEDURE

FGG will be done simultaneous with implant placement

Two Steps protocol

Conventional FGG protocol, prior to implant placement

Group Type ACTIVE_COMPARATOR

Two Steps Protocol

Intervention Type PROCEDURE

Conventional FGG protocol, prior to implant placement

Interventions

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One Step Protocol

FGG will be done simultaneous with implant placement

Intervention Type PROCEDURE

Two Steps Protocol

Conventional FGG protocol, prior to implant placement

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adults at or above the age of 18.
* Lower Posterior missing tooth/ teeth with minimal KT \< 2mm
* Sufficient alveolar ridge length minimum 13-15 mm to IAN

•. Sufficient alveolar ridge width minimum of 6 mm
* Patients able to tolerate surgical periodontal procedures.
* Patients who provided an informed consent and accepted the one-year follow-up period.

Exclusion Criteria

* Patients diagnosed with periodontal diseases (Caton et al., 2018).
* Current or previous smokers.
* Pregnant and lactating females.
* Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking intravenous Bisphosphonates for treatment of osteoporosis.
* Patients with active infection related to the site of implant.
* Patients with parafunctional habits.
* Patients with shallow vestibule
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Misr International University

OTHER

Sponsor Role lead

International Dental Contiuing Education

NETWORK

Sponsor Role collaborator

Responsible Party

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Ahmed Abo El Futtouh

CEO and Clinical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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International Dental Continuing Education

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Nourhan G AbdelAziz, Masters degree periodontology

Role: CONTACT

+00201064249441

Facility Contacts

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Ahmed Abou El Fetthouh, PhD

Role: primary

Other Identifiers

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IDCE - 13

Identifier Type: -

Identifier Source: org_study_id

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