Immediate Implants in Front Teeth With Bone Loss: Regeneration and Temporary Crown in a Randomized Clinical Study (GBR / RCT)

Immediate Implant Placement in Buccal Dehiscence Aesthetic Sites With Simultaneous Regeneration and Immediate Provisionalization: a Controlled Randomized Clinical.

This clinical trial investigates the biological and clinical outcomes of immediate implant placement in aesthetic areas presenting with buccal bone dehiscence. Traditionally, these defects are treated with a bone graft and covered using a collagen membrane; however, there is ongoing debate about whether the membrane is necessary for optimal regeneration. This study proposes the use of a connective tissue graft instead of a collagen membrane, aiming to improve soft tissue volume and aesthetics without compromising bone healing.

The objective of the study is to evaluate whether the use of an autogenous connective tissue graft in combination with a deproteinized bovine bone mineral with collagen (DBBM-C) achieves results that are not inferior to the conventional protocol that uses DBBM-C and a collagen membrane. The main outcome variable is the vertical buccal bone gain measured after twelve months of healing.

The study design is a randomized controlled clinical trial including twenty-four patients divided equally into two groups. Each participant will attend eight follow-up visits over twelve months. After atraumatic tooth extraction, immediate implants (BLC, Straumann) will be placed using a prosthetically guided protocol. Buccal dehiscence will be measured intraoperatively, and a partial-thickness tunnel flap will be prepared to allow soft tissue adaptation and graft placement.

In the control group, the defect will be filled with DBBM-C and covered with a collagen membrane stabilized with horizontal mattress sutures. In the test group, the defect will receive DBBM-C covered by a connective tissue graft harvested from the palate and fixed in a similar manner. When primary stability is equal to or greater than 35 N/cm, an immediate screw-retained provisional crown will be delivered; if stability is lower, a customized healing abutment or Maryland-type provisional will be used instead.

After three months, digital impressions will be taken to fabricate the definitive zirconia restoration. All restorative steps will be performed by experienced clinicians using a standardized digital workflow. Patients will follow routine postoperative care instructions, including soft diet and restricted brushing in the surgical area for one week.

The main benefits of this study include advancing the understanding of regeneration strategies for buccal bone dehiscence and improving clinical decision-making in immediate implant protocols. Participants are also expected to benefit from implant-supported rehabilitation, functional restoration, and aesthetic improvement. The potential risks are minimal and limited to typical surgical complications such as discomfort, swelling, or minor infection, which will be managed following established clinical protocols.

If a patient declines participation, conventional implant treatment will be offered, or alternative prosthetic options such as fixed or removable restorations will be provided. Any intra- or postoperative complications during the study will be treated promptly and documented according to institutional standards.

The biomaterials used include BLC Straumann implants, Bio-Oss Collagen (DBBM-C), Bio-Gide collagen membranes, and appropriate suture materials. Procedures will employ standard periodontal and tunneling instruments, as well as a digital intraoral scanner for accurate prosthetic fabrication.

Statistical analysis will involve descriptive and inferential methods. The Kolmogorov-Smirnov test will assess normality, and mixed ANOVA models will evaluate differences between groups and across time points. Covariate adjustment will be performed using ANCOVA when necessary, and intra- and inter-examiner reliability will be tested with the intraclass correlation coefficient. The level of statistical significance will be set at 0.05.

The expected outcome is that the use of an autogenous connective tissue graft will demonstrate bone regeneration results equivalent to those obtained with a collagen membrane, while potentially improving soft tissue thickness and aesthetic integration. This finding would support the clinical use of soft tissue grafts as an alternative to collagen membranes in immediate implant placement within aesthetic regions showing buccal dehiscence.

All study procedures follow the principles of the Declaration of Helsinki and ethical standards for human clinical research. Participants will receive detailed information about the study protocol and will sign informed consent before inclusion.

In summary, this study aims to determine whether a connective tissue graft can safely replace a collagen membrane in the management of buccal dehiscence during immediate implant placement, offering comparable regenerative outcomes with possible superior soft tissue aesthetics.

Study Overview

• Status: Not yet recruiting
• Conditions: Connective Tissue Graft; Connective Tissue Graft Harvesting; Soft Tissue Management in Subcrestal Dental Implants; Immediate Dental Implant Placement
• Intervention / Treatment: Procedure: immediate implant placement with DBBM-C with collagen membrane; Procedure: immediate implant placement with DBBM-C and connective tissue graft

Detailed Description

Introduction The standard treatment for buccal bone dehiscence (BBD) around dental implants is the use of a bone graft combined with a collagen membrane. However, there is continuing debate regarding whether the addition of a collagen membrane is essential for optimal regenerative outcomes. In the context of immediate implant placement (IIP) at sites with BBD, it has been proposed that replacing the collagen membrane with an autogenous soft tissue graft may improve peri-implant tissue volume and enhance aesthetic results. This clinical trial is designed to evaluate the biological and clinical performance of a connective tissue graft compared with a collagen membrane when used together with deproteinized bovine bone mineral with collagen (DBBM-C) for simultaneous regeneration in aesthetic areas.

Objectives The main objective of this randomized clinical trial is to evaluate the non-inferiority of buccal bone defect resolution after immediate implant placement in aesthetic regions, comparing two regenerative approaches: (1) autogenous connective tissue graft combined with DBBM-C and (2) collagen membrane combined with DBBM-C. The study aims to determine whether a connective tissue graft can achieve comparable regenerative and aesthetic results to the conventional collagen membrane technique.

Materials and Methods This controlled, randomized clinical trial will be conducted at the Department of Periodontology within the research line of surgical techniques, morbidity, and biomaterials. The study protocol is version 1.0, dated March 18, 2025. A total of twenty-four patients will be included and randomly assigned into two equal groups of twelve participants each (test and control). The study duration will be twelve months, and each participant will attend eight scheduled visits.

Sample Size Calculation The calculation was based on the main outcome variable-vertical buccal bone gain after twelve months. Assuming no real difference between treatment groups, twenty-four patients will provide 90% power for the lower bound of the one-sided 95% confidence interval to remain above the non-inferiority margin of 1.5 mm.

Inclusion and Exclusion Criteria Patients indicated for immediate implant placement in aesthetic areas presenting with buccal bone dehiscence will be eligible. All participants must be in general good health and suitable for oral surgery. Specific inclusion and exclusion criteria will follow standard clinical and ethical guidelines for implant therapy.

Surgical Procedure Atraumatic tooth extraction will be performed without flap elevation, and the socket will be carefully curetted to remove granulation tissue. Buccal bone dehiscence will be confirmed intraoperatively.

Implants (BLC, Straumann®, Basel, Switzerland) will be placed following the manufacturer's instructions and prosthetically guided planning. The buccal defect's width and depth will be measured with a periodontal probe (PCP UNC-15, HuFriedy®, Chicago, IL). A partial-thickness tunnel flap will be extended beyond the defect to allow regeneration and soft tissue adaptation.

All defects will be filled with DBBM-C (Bio-Oss® Collagen, Geistlich Pharma AG, Switzerland). After graft placement, participants will be randomly assigned to one of two groups:

• Control group: DBBM-C covered with a collagen membrane (Bio-Gide®, Geistlich Pharma AG, Switzerland) stabilized using horizontal mattress sutures (6/0 monofilament).
• Test group: DBBM-C covered with an autogenous connective tissue graft harvested from the palatal mucosa (approximately 1.5 mm thick) and stabilized similarly.

When primary stability ≥35 N/cm is achieved, an immediate screw-retained provisional restoration will be delivered without occlusal or eccentric contacts. If torque <35 N/cm, a customized healing abutment and a Maryland-type provisional will be fabricated.

Postoperative Care and Prosthetic Phase Patients will follow a soft diet and maintain oral hygiene while avoiding brushing at the surgical site for one week. After three months, digital impressions will be taken using an intraoral scanner (TRIOS 3, 3Shape, Copenhagen, Denmark), and a definitive screw-retained zirconia restoration will be fabricated and placed. All prosthetic work will be performed by experienced clinicians and dental technicians to ensure standardization.

Benefits and Risks Potential benefits include both direct and indirect effects. Clinically, patients will receive implant-supported rehabilitation that enhances masticatory function, occlusion, and aesthetics. Scientifically, participants will contribute to expanding knowledge on predictable management of buccal bone dehiscence in immediate implant placement.

Risks are minimal and limited to standard surgical complications, such as pain, swelling, bleeding, or minor infection, all of which will be managed according to established clinical protocols.

Alternative Treatments Patients who decline participation will be offered the standard implant procedure as in the control group. If implant therapy is not accepted, fixed or removable prostheses will be proposed to ensure functional and aesthetic rehabilitation.

Management of Complications Any postoperative complications will be treated according to clinical guidelines using pharmacological or surgical interventions as needed. All adverse events will be documented and managed to ensure patient safety and ethical compliance.

Materials and Equipment Materials include BLC implants (Straumann®, Basel, Switzerland), Bio-Oss® Collagen (DBBM-C), Bio-Gide® collagen membranes, and suture materials (polyvinylidene fluoride 6/0, Seralene®, and polyamide 5/0, Seralon®). Adhesive PeryAcril® 90HV (Glustitch Inc., Canada) will be used as needed. Standard surgical instruments such as periodontal probes, scalpels, Orban knives, Allen elevators, and tunneling instruments (HuFriedy®, Chicago, IL) will be used. The TRIOS 3 intraoral scanner (3Shape, Copenhagen, Denmark) will support the digital workflow.

Statistical Analysis Descriptive and inferential analyses will be performed. Descriptive statistics will include mean, standard deviation, median, range, and interquartile range for continuous variables, and frequency and percentage for categorical variables. Data normality will be tested using the Kolmogorov-Smirnov test. The primary outcome will be analyzed using repeated-measures mixed ANOVA to assess intergroup and intragroup differences over time. ANCOVA will be applied when covariate adjustment is necessary. Reliability will be measured using the intraclass correlation coefficient (ICC) for intra- and inter-examiner agreement. The significance level is set at α = 0.05.

Ethical Considerations All procedures comply with the Declaration of Helsinki and current national standards for human clinical research. Each participant will receive detailed verbal and written information and must provide signed informed consent before inclusion. Data confidentiality will be maintained at all stages.

Expected Outcomes and Clinical Significance This study aims to determine whether an autogenous connective tissue graft offers non-inferior bone regeneration compared to the conventional collagen membrane approach while improving soft tissue thickness and aesthetics. Demonstrating non-inferiority would validate the use of soft tissue grafts as a biologically sound, clinically effective alternative for simultaneous hard and soft tissue management during immediate implant placement in aesthetic regions affected by buccal dehiscence.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• • Adult patients with ⩾ 25 years of age.

  • Ability to understand all the study procedures and to comply with them along the entire study period. Ability and willingness to give written informed consent.
  • Periodontal health in an intact or reduced periodontium (2017 World Workshop in Periodontal and Peri-implant Diseases and Conditions) (G. Caton et al., 2018).
  • Good level of oral hygiene (Plaque Index < 20%) (Löe, 1967).
  • Failing tooth in the anterior area of the maxillary arch (incisors, canines and premolars).
  • Bone availability for a prosthetically driven single-unit immediate implant.
  • A peri-implant BBD with a minimum vertical dimension height (VDH) of 3mm, detected by means of a CT imaging.
  • Presence of adjacent teeth.
  • Presence of antagonist teeth.
  • Keratinized mucosa of at least 2mm on the buccal aspect of the tooth to be extracted.

Exclusion Criteria:

• Smokers ⩾ 10 cigarettes per day.

  • Pregnant women or lactating females.
  • Acute periapical infection.
  • Presence of buccal/palatal and/or interproximal gingival recession in the target tooth.
  • Any systemic disease or medication that contraindicates implant treatment or could influence the outcome of the therapy (i.e., non-controlled diabetes mellitus, osteoporosis, radiotherapy, bisphosphonate medication, ...).
  • Long-term non-steroidal anti-inflammatory drug therapy (⩾ 3 months).
  • Lack of primary manual stability of the implant during installation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: immediate implant placement with DBBM-C with collagen membrane; treatment of failing tooth in the anterior area of the maxillary arch (incisors, canines and premolars) with immediate implante placement in cases with buccal bone dehiscence (minimum 3mm) resolution with the gold standard membrane collagen plus DBBM-C (deproteinized bovine bone mineral with 10% collagen).	Procedure: immediate implant placement with DBBM-C with collagen membrane; treatment of failing tooth in the anterior area of the maxillary arch (incisors, canines and premolars) with immediate implante placement in cases with buccal bone dehiscence (minimum 3mm) resolution with the gold standard membrane collagen plus DBBM-C (deproteinized bovine bone mineral with 10% collagen).
Experimental: immediate implant placement with DBBM-C and connective tissue graft; treatment of failing tooth in the anterior area of the maxillary arch (incisors, canines and premolars) with immediate implante placement in cases with buccal bone dehiscence (minimum 3mm) resolution of autogenous connective tissue graft plus DBBM-C (deproteinized bovine bone mineral with 10% collagen).	Procedure: immediate implant placement with DBBM-C and connective tissue graft; treatment of failing tooth in the anterior area of the maxillary arch (incisors, canines and premolars) with immediate implante placement in cases with buccal bone dehiscence (minimum 3mm) resolution of autogenous connective tissue graft plus DBBM-C (deproteinized bovine bone mineral with 10% collagen).; Other Names: immediate implant placement with xenograft and connective tissue graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome variable will be buccal bone dehiscence resolution.	To study volumetic changes in the vestibular aspect of 24 patients throughout 12-months follow-up period in a RCT.	From enrollment to end of the treatment and 12 months follow-up.

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya
• Collaborators: Institut Straumann AG

Publications and helpful links

General Publications

• Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
• Chappuis V, Araujo MG, Buser D. Clinical relevance of dimensional bone and soft tissue alterations post-extraction in esthetic sites. Periodontol 2000. 2017 Feb;73(1):73-83. doi: 10.1111/prd.12167.
• Blanco J, Carral C, Argibay O, Linares A. Implant placement in fresh extraction sockets. Periodontol 2000. 2019 Feb;79(1):151-167. doi: 10.1111/prd.12253.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Connective tissue graft; emergence profile; immediate implant placement; volumen changes in vestibular plate; immediate aesthetic crown
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Transplantation; Transplantation, Heterologous
• Other Study ID Numbers: PER-ECL-2023-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The results on volumetic changes in the vestibular aspect after a year of the immediate implante placement

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No