Novel Soft Tissue Augmentation Technique Using Free Gingival Graft Simultaneous With Implant Placement in Posterior Mandible: A 1-year Randomized Clinical Trial
Overview
- Phase
- N/A
- Intervention
- One Step Protocol
- Conditions
- Free Gingival Graft
- Sponsor
- Misr International University
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Keratinized tissue width
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
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.
Investigators
Ahmed Abo El Futtouh
CEO and Clinical Director
International Dental Contiuing Education
Eligibility Criteria
Inclusion Criteria
- •Adults at or above the age of
- •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
Arms & Interventions
One Step Protocol
FGG simultaneous with delayed implant placement
Intervention: One Step Protocol
Two Steps protocol
Conventional FGG protocol, prior to implant placement
Intervention: Two Steps Protocol
Outcomes
Primary Outcomes
Keratinized tissue width
Time Frame: 0 - 3 - 6 - 12 months
Measure Clinically and Digitally at 0 - 3 - 6 - 12 months postoperative
Secondary Outcomes
- 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)