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AzTrials

Immediate Dental Implant PlacementNCT07518823

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.

A study testing immediate implant placement + SG and Groupe 2 : CTG in people with Immediate Dental Implant Placement and Connective Tissue Graft, run by Saint-Joseph University at 1 site in Lebanon.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
immediate implant placement + SG and Groupe 2 : CTG
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteLebanon
Study dates
2 Jan 2025to 2 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • - 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

Trial locations and contacts

1 site in 1 country.

Lebanon1 site
  • Saint Joseph University

    Beirut, 0000

Other trials in Lebanon

About this 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

Read the 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.

Being tested
immediate implant placement + SG, Groupe 2 : CTG
Keywords
Bone substitutes, connective tissue, dental implant, hard tissues, soft tissue, tooth extraction, tooth socket

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • immediate implant placement + SGProcedure or surgery

    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 2 : CTGProcedure or surgery

    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
Study groups in NCT07518823
Study groupRoleWhat they receive
Groupe 2: test group : CTGExperimentalCTG
Receives: Procedure: Groupe 2 : CTG
Groupe 1 : control group : SGActive comparatorSG
Receives: Procedure: immediate implant placement + SG

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 6 months

Secondary outcomes (4)
  1. 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.

    Measured: Baseline and 6 months

  2. 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.

    Measured: Baseline and 6 months

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

    Calculated from superimposed STL datasets.

    Measured: Baseline and 6 months

  4. 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.

    Measured: Perioperative (Day 1) and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2026
  2. Study start2 Jan 2025
  3. Primary completion2 Mar 2026
  4. Study completion2 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07518823
Sponsor's protocol ID
FMDSF 167
Status last verified
Apr 2026
First submitted
26 Mar 2026
Last updated
9 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A study testing immediate implant placement + SG and Groupe 2 : CTG in people with Immediate Dental Implant Placement and Connective Tissue Graft, run by Saint-Joseph University at 1 site in Lebanon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in vertical buccal bone height (mm) from baseline to 6 months (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07518823, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.

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