Novel Soft Tissue Augmentation Technique Using Free Gingival Graft Simultaneous With Implant Placement in Posterior Mandible

Not Applicable

Not yet recruiting

• Conditions: Free Gingival Graft; Free Gingival Graft Volume Change; Keratinized Tissue

• Registration Number: NCT06645925
• Lead Sponsor: Misr International University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-05
• Study First Submitted QC: 2024-10-15
• Study First Posted: 2024-10-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Study Start: 2025-06-01
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 22

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Keratinized tissue width	0 - 3 - 6 - 12 months	Measure Clinically and Digitally at 0 - 3 - 6 - 12 months postoperative

Secondary Outcome Measures

Name	Time	Method
Midfacial margin changes	12 Months
Crestal bone level changes	12 Months
Bone labial to the implant	12 Months
Survival Rate	12 Months
Linear changes in buccal soft tissue contour	0-3, 0-6, 0-12 Months
Interdental Papilla height changes	12 months

Trial Locations

Locations (1)

IDCE; 🇪🇬 Cairo, Egypt