Hard and Soft Tissue Changes Following Immediate Implant Placement With Buccal Gap Management: Comparing the Use of Deproteinized Bovine Bone Mineral Socket Grafting and Sub-epithelial Connective Tissue Graft in a 6-month Pilot Study.
NCT07518823 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2026-04-09
Summary
This study aims to assess hard and soft tissue changes after immediate implant placement, comparing the use of a deproteinized bovine bone mineral and sub-epithelial connective tissue graft in the management of the buccal gap.
This study involves clinical and radiographic evaluation to assess tissue changes following immediate implant placement. Preoperative procedures include a clinical diagnosis, clinical measurements, intraoral scanning, and CBCT analysis. After flap elevation, atraumatic extraction is performed followed by immediate implant placement. Buccal gap management is done using either a deproteinized bovine bone mineral or a connective tissue graft (placed on the flap).
Postoperative assessments, including intraoral scans and CBCT imaging, are conducted at six months. To evaluate hard and soft tissue changes, the scans and CBCTs are superimposed using a digital software to quantify differences and statistical analysis is then performed
Conditions
- Immediate Dental Implant Placement
- Connective Tissue Graft
- Bone Substitutes
Interventions
- PROCEDURE
-
immediate implant placement + SG
Before surgery, patients will rinse with 0.12% chlorhexidine solution for one minute. Local anesthesia will be administered using 2% articaine with 1:100,000 epinephrine. A 15c (Swann-Morton®) blade is used to make the incision, and the flap is elevated. The tooth will be extracted atraumatically to preserve the buccal ridge, using a periotome and, if feasible, rotational forceps. Elevators will be used when necessary, ensuring no pressure applied to the vestibular plate. The implant site is prepared following the manufacturer's drilling sequence to achieve primary stability (\>35 Ncm). After implant placement, the fixture-socket gap will be addressed based on group assignment: • Control Group: The buccal gap will be filled with a deproteinized bovine bone mineral (DBBM) (OCS-B®, NIBEC, Korea ).
- PROCEDURE
-
Groupe 2 : CTG
Before surgery, patients will rinse with 0.12% chlorhexidine solution for one minute. Local anesthesia will be administered using 2% articaine with 1:100,000 epinephrine. A 15c (Swann-Morton®) blade is used to make the incision, and the flap is elevated. The tooth will be extracted atraumatically to preserve the buccal ridge, using a periotome and, if feasible, rotational forceps. Elevators will be used when necessary, ensuring no pressure applied to the vestibular plate. The implant site is prepared following the manufacturer's drilling sequence to achieve primary stability (\>35 Ncm). After implant placement, the fixture-socket gap will be addressed based on group assignment: • Test Group 1 : The gap will be left empty, and a sub-epithelial connective tissue graft will be harvested from the palate then de-epithelialized. The CTG will be sutured to the flap
Sponsors & Collaborators
-
Saint-Joseph University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-02
- Primary Completion
- 2026-03-02
- Completion
- 2026-03-02
Countries
- Lebanon
Study Locations
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