NCT06645925

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Nov 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Nov 2025Dec 2027

First Submitted

Initial submission to the registry

September 5, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

September 5, 2024

Last Update Submit

January 27, 2026

Conditions

Free Gingival GraftFree Gingival Graft Volume ChangeKeratinized Tissue

Keywords

FGGDelayed implant placementKeratinized mucosa

Outcome Measures

Primary Outcomes (1)

  • Keratinized tissue width

    Measure Clinically and Digitally at 0 - 3 - 6 - 12 months postoperative

    0 - 3 - 6 - 12 months

Secondary Outcomes (6)

  • Linear changes in buccal soft tissue contour

    0-3, 0-6, 0-12 Months

  • Interdental Papilla height changes

    12 months

  • Midfacial margin changes

    12 Months

  • Crestal bone level changes

    12 Months

  • Bone labial to the implant

    12 Months

  • +1 more secondary outcomes

Study Arms (2)

One Step Protocol

EXPERIMENTAL

FGG simultaneous with delayed implant placement

Procedure: One Step Protocol

Two Steps protocol

ACTIVE COMPARATOR

Conventional FGG protocol, prior to implant placement

Procedure: Two Steps Protocol

Interventions

One Step ProtocolPROCEDURE

FGG will be done simultaneous with implant placement

One Step Protocol
Two Steps ProtocolPROCEDURE

Conventional FGG protocol, prior to implant placement

Two Steps protocol

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Dental Continuing Education

Cairo, 11347, Egypt

RECRUITING

Central Study Contacts

Nourhan G AbdelAziz, Masters degree periodontology

CONTACT

+00201064249441Nourhannegamal259@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CEO and Clinical Director

Study Record Dates

First Submitted

September 5, 2024

First Posted

October 17, 2024

Study Start

November 1, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 30, 2027

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)