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.

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

Study Overview

• Status: Completed
• Conditions: Bone Substitutes; Connective Tissue Graft; Immediate Dental Implant Placement
• Intervention / Treatment: Procedure: Groupe 2 : CTG; Procedure: immediate implant placement + SG

Detailed Description

Dental implant treatment has become crucial in dentistry, evolving with advancements in biomaterials and techniques to ensure not only implant survival but also long-term esthetic and functional success. A classification system for implant placement in relation to the extracted tooth was proposed by the ITI's Third Consensus Conference. Type I is defined as the placement of an implant immediately after tooth extraction : immediate implant placement (IIP). IIP has several advantages, including fewer surgical interventions and a shorter overall treatment duration. It also achieves high survival rates in comparison with delayed implant placement, at 98.5% and 98.9%, respectively.

Horizontal and vertical ridge alterations are observed after IIP, as several studies have shown that IIP per se doesn't prevent alveolar ridge reduction. Seyssens et al.'s 10-year prospective case series showed that 3 out of 18 cases had no detectable buccal bone, indicating the possible limitations of IIP in preserving bone volume.

The alveolar socket's dimensions exceed the implant's diameter, creating a gap between the coronal portion of the implant and the surrounding bone, referred to as the "fixture-socket gap." Altough this gap may close in some cases, studies have shown that it typically does not fill completely without the use of biomaterials.

In the aesthetic zone between the second contralateral premolars, the size of the gap at the buccal aspect is important for minimizing bone alterations, as the buccal bone plate is prone to resorption, which can lead to soft tissue recession. Studies demonstrate that buccal gaps ≤ 2 mm can heal without the need for grafts or barriers, while gaps >2 mm are unlikely to achieve complete bone fill as larger gaps may affect spontaneous bone healing. Chen et al. and Grassi et al. reported no significant impact of gap size on horizontal buccal bone resorption after IIP with or without socket grafting (SG).

In fact, the dimensions of the gap and the approach for managing it remains debated with uncertainty about the procedures to minimize buccal bone resorption and soft tissue recession. Several studies showed that the use of biomaterials such as xenografts in the fixture-socket preserve socket volume and reduces the bone dimensional changes that occurs following IIP.

A meta-analysis showed 0.59 mm (or 54%) less horizontal buccal bone resorption with IIP combined with SG compared to IIP alone.

Using a connective tissue graft (CTG) at the buccal aspect of immediate implants is an another regenerative approach that has been shown in a recent systematic review to reduce apical migration of the mid facial soft tissue level by 0.41 mm. Increased soft tissue thickness may protect against bone resorption, according to recent studies. A pilot study by Aroca et al. found that placing a CTG during IIP without SG reduces horizontal changes in the alveolar ridge and preserves tissue contour but doesn't affect vertical bone resorption. Combining IIP with a CTG could be an effective option to address hard tissue changes and maintain tissue aesthetics.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon, 0000
    • Saint Joseph University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• - 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Groupe 2: test group : CTG; CTG	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
Active Comparator: Groupe 1 : control group : SG; SG	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 ).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in horizontal buccal bone thickness (mm) from baseline to 6 months	Measured on CBCT superimposition at 1-5 mm apical to the implant platform.	Baseline and 6 months
Change in buccal soft tissue thickness (mm) from baseline to 6 months	Measured by STL/CBCT superimposition at 1-5 mm apical to the gingival margin.	Baseline and 6 months
Percentage change in buccal soft tissue volume (%) from baseline to 6 months	Calculated from superimposed STL datasets.	Baseline and 6 months
Buccal gap width (mm) at implant placement and its association with bone changes at 6 months	S-IC and S-OC measured clinically at surgery and correlated with bone changes.	Perioperative (Day 1) and 6 months

Collaborators and Investigators

• Sponsor: Saint-Joseph University

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2025
• Primary Completion (Actual): March 2, 2026
• Study Completion (Actual): March 2, 2026

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: dental implant; connective tissue; soft tissue; tooth extraction; tooth socket; Bone substitutes; hard tissues
• Other Study ID Numbers: FMDSF 167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No