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Using a free gingival graft to build gum tissue around lower back dental implants

Q: Who is a good fit for trial NCT06645925?

Adults (≥18) missing lower posterior tooth/teeth with keratinized mucosa <2 mm, adequate alveolar ridge length (13–15 mm) and width (≥6 mm), medically fit for oral surgery, non-smokers, and willing to complete one-year follow-up.

Q: Who should not enroll in trial NCT06645925?

Patients with active periodontal disease, current or past smokers, uncontrolled systemic conditions (e.g., uncontrolled diabetes), pregnant or lactating women, those on IV bisphosphonates, with active local infection, parafunctional habits, or a shallow vestibule are unlikely to benefit or be eligible.

Q: What is the potential benefit of this trial?

If successful, the one-step technique could shorten treatment time and increase stable keratinized gum around lower implants, reducing soft-tissue inflammation and long-term implant complications.

Q: How have similar studies performed?

Free gingival grafting is a well-established method to increase keratinized tissue, but direct comparisons of simultaneous versus staged grafting with implant placement are limited and have produced mixed results.

Novel Soft Tissue Augmentation Technique Using Free Gingival Graft Simultaneous With Implant Placement in Posterior Mandible: A 1-year Randomized Clinical Trial

Not applicable Interventional Misr International University · NCT06645925

This test sees if placing a free gingival graft at the same time as a lower back dental implant produces more keratinized gum tissue and better soft-tissue volume than doing the graft before implant placement for adults missing lower back teeth with under 2 mm of gum tissue.

Quick facts

Phase	Not applicable
Study type	Interventional
Enrollment	22 (estimated)
Ages	18 Years to 50 Years
Sex	All
Sponsor	Misr International University Academic / other
Locations	1 site (Cairo)
Trial ID	NCT06645925 on ClinicalTrials.gov

What this trial studies

This trial compares two surgical approaches for increasing keratinized tissue around posterior lower implants: a one-step protocol that performs a free gingival graft at the time of implant placement, and a two-step protocol that places the graft before implant surgery. Primary outcomes include keratinized tissue width gain and linear and volumetric changes in the buccal soft tissue, with secondary evaluation of hard tissue changes after implant restoration. Eligible adults have missing lower posterior teeth with keratinized mucosa <2 mm and adequate alveolar ridge dimensions, meet medical safety criteria, and agree to one-year follow-up. Procedures are performed at International Dental Continuing Education in Cairo in collaboration with Misr International University.

Who should consider this trial

Good fit: Adults (≥18) missing lower posterior tooth/teeth with keratinized mucosa <2 mm, adequate alveolar ridge length (13–15 mm) and width (≥6 mm), medically fit for oral surgery, non-smokers, and willing to complete one-year follow-up.

Not a fit: Patients with active periodontal disease, current or past smokers, uncontrolled systemic conditions (e.g., uncontrolled diabetes), pregnant or lactating women, those on IV bisphosphonates, with active local infection, parafunctional habits, or a shallow vestibule are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the one-step technique could shorten treatment time and increase stable keratinized gum around lower implants, reducing soft-tissue inflammation and long-term implant complications.

How similar studies have performed: Free gingival grafting is a well-established method to increase keratinized tissue, but direct comparisons of simultaneous versus staged grafting with implant placement are limited and have produced mixed results.

Eligibility criteria

Show full inclusion / exclusion criteria

Inclusion Criteria:

* Adults at or above the age of 18.
* Lower Posterior missing tooth/ teeth with minimal KT \&lt; 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

Where this trial is running

Cairo

International Dental Continuing Education — Cairo, Egypt (Recruiting)

Study contacts

Study coordinator: Nourhan G AbdelAziz, Masters degree periodontology
Email: Nourhannegamal259@gmail.com
Phone: +00201064249441

How to participate

Review the eligibility criteria above with your treating physician.
Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov → Find more trials like this →

Conditions Free Gingival Graft Free Gingival Graft Volume Change Keratinized Tissue FGG Delayed implant placement Keratinized mucosa

Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.