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 | Completed

• 1 other identifier: FMDSF 167
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Bone substitutes; connective tissue; dental implant; hard tissues; soft tissue; tooth extraction; tooth socket

Outcome Measures

Primary Outcomes (1)

• Change in vertical buccal bone height (mm) from baseline to 6 months

  Measured on CBCT superimposition as the vertical linear distance (VLD) between the buccal crest at baseline and 6 months along the implant axis. Negative values indicate resorption.

  Baseline and 6 months

Secondary Outcomes (4)

• Change in horizontal buccal bone thickness (mm) from baseline to 6 months

  Baseline and 6 months

• Change in buccal soft tissue thickness (mm) from baseline to 6 months

  Baseline and 6 months

• Percentage change in buccal soft tissue volume (%) from baseline to 6 months

  Baseline and 6 months

• Buccal gap width (mm) at implant placement and its association with bone changes at 6 months

  Perioperative (Day 1) and 6 months

Study Arms (2)

Groupe 2: test group : CTG

EXPERIMENTAL

CTG

Procedure: Groupe 2 : CTG

Groupe 1 : control group : SG

ACTIVE COMPARATOR

SG

Procedure: immediate implant placement + SG

Interventions

immediate implant placement + SG PROCEDURE

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 ).

Groupe 1 : control group : SG

Groupe 2 : CTG PROCEDURE

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

Groupe 2: test group : CTG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years of age)
• Single hopless tooth in need for extraction in the maxillary or mandible area from second premolar to second premolar
• Intact extraction socket; in the event of a potential facial fenestration, this should be no more than 3 mm apical from the marginal bone crest.
• Buccal bone plate thickness ≥ 1.5 mm.
• Sufficient apical bone to attain implant primary stability (a minimum of 35 N cm insertion torque)

You may not qualify if:

• \- Pregnant or lactating women
• Patients with systemic diseases or inflammatory and autoimmune diseases affecting the oral cavity
• Infected socket or periapical pathosis
• History of radiotherapy or chemotherapy within the past 2 years
• General contraindications for dental or surgical treatments
• Uncontrolled diabetes
• Concurrent or previous immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy
• Unable or unwilling to return for follow-up or comply with study procedures

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint Joseph University

Beirut, 0000, Lebanon

Location

Related Publications (1)

• 1. Khoury J, Ghosn N, Mokbel N, Naaman N. Buccal Bone Thickness Overlying Maxillary Anterior Teeth: A Clinical and Radiographic Prospective Human Study. Implant Dent. 2016 Aug;25(4):525-31. 2. Cosyn J, Blanco J. EAO Position Paper: Immediate Implant Placement: Managing Hard and Soft Tissue Stability from Diagnosis to Prosthetic Treatment. Int J Prosthodont. 2023 Nov 1;36(5):533-45. 3. Levine RA, Dias DR, Wang P, Araújo MG. Effect of the buccal gap width following immediate implant placement on the buccal bone wall: A retrospective cone-beam computed tomography analysis. Clin Implant Dent Relat Res. 2022 Aug;24(4):403-13. 4. Chatzopoulos GS, Wolff LF. Survival Rates and Factors Affecting the Outcome Following Immediate and Delayed Implant Placement: A Retrospective Study. J Clin Med. 2022 Aug 7;11(15):4598. 5. Guglielmi D, Di Domenico GL, Aroca S, Vignoletti F, Ciaravino V, Donghia R, et al. Soft and hard tissue changes after immediate implant placement with or without a sub-epithelial connective tissue graft: Results from a 6-month pilot randomized controlled clinical trial. J Clin Periodontol. 2022 Oct;49(10):999-1011. 6. Seyssens L, Eghbali A, Cosyn J. A 10-year prospective study on single immediate implants. J Clin Periodontol. 2020 Oct;47(10):1248-58. 7. Fettouh AIA, Ghallab NA, Ghaffar KA, Mina NA, Abdelmalak MS, Abdelrahman AAG, et al. Bone dimensional changes after flapless immediate implant placement with and without bone grafting: Randomized clinical trial. Clin Implant Dent Relat Res. 2023 Apr;25(2):271-83. 8. Naji BM, Abdelsameaa SS, Alqutaibi AY, Said Ahmed WM. Immediate dental implant placement with a horizontal gap more than two millimetres: a randomized clinical trial. Int J Oral Maxillofac Surg. 2021 May;50(5):683-90. 9. Seyssens L, Eeckhout C, Cosyn J. Immediate implant placement with or without socket grafting: A systematic review and meta-analysis. Clin Implant Dent Relat Res. 2022 Jun;24(3):339-51. 10. Elsheikh HAE, Abdelsameaa SE, Elbah

  BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Primary objective : To assess radiologically the vertical buccal bone dimensional changes six months after immediate implant placement, comparing the use of a deproteinized bovine bone mineral, sub-epithelial connective tissue graft and collagen matrix in the buccal gap. Secondary objectives : * To assess radiologically after immediate implant placement, comparing the use of a deproteinized bovine bone mineral and sub-epithelial connective tissue graft in the buccal gap (at six months): * The horizontal buccal bone dimensional changes * The horizontal soft tissue thickness changes * The volumetric soft tissue changes * To assess the buccal gap dimensions on the buccal bone changes.

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 9, 2026
• Study Start: January 2, 2025
• Primary Completion: March 2, 2026
• Study Completion: March 2, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

LE (1)