Immediate Implants in Front Teeth With Bone Loss: Regeneration and Temporary Crown in a Randomized Clinical Study

NCT07415486 | Not Yet Recruiting DMC

• 1 other identifier: PER-ECL-2023-04
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Immediate Dental Implant Placement; Connective Tissue Graft; Connective Tissue Graft Harvesting; Soft Tissue Management in Subcrestal Dental Implants

Keywords

Connective tissue graft; volumen changes in vestibular plate; immediate implant placement; emergence profile; immediate aesthetic crown

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

immediate implant placement with DBBM-C with collagen membrane

ACTIVE COMPARATOR

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

immediate implant placement with DBBM-C and connective tissue graft

EXPERIMENTAL

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

Interventions

immediate implant placement with DBBM-C and connective tissue graft PROCEDURE

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).

Also known as: immediate implant placement with xenograft and connective tissue graft

immediate implant placement with DBBM-C and connective tissue graft

immediate implant placement with DBBM-C with collagen membrane PROCEDURE

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).

immediate implant placement with DBBM-C with collagen membrane

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead
• Institut Straumann AG: collaborator

Related Publications (3)

• 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.

  PMID: 16307569 BACKGROUND

• 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.

  PMID: 28000281 BACKGROUND

• 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.

  PMID: 30892772 BACKGROUND

MeSH Terms

Interventions

Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Although the gold standard therapy for BBD in implant sites is the use of a bone graft with a collagen membrane, there is a clinical debate about the need to add a collagen membrane to cover the bone graft. In the context of flapless IIP with BBD, it has been speculated that the use of a soft tissue graft -instead of a collagen membrane- may help to improve peri-implant tissue volume and patients' aesthetics perception.

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: February 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: February 17, 2026

Record last verified: 2025-12