Socket Shield Technique and Guided Bone Regeneration

NCT ID: NCT05990283

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2023-01-20

Brief Summary

Among the individuals who applied to the Department of Periodontology, Faculty of Dentistry, Health Sciences University between 2019 and 2021, patients with an unrestorable tooth in the maxillary esthetic region and required implant placement were included in this randomized clinical trial. Before implant surgery, patients were randomized into socket shield technique and guided bone regeneration groups. While the buccal gap was untreated in the socket shield group, a xenograft, and membrane were applied in the regeneration group. Peri-implant pocket depth, modified plaque index, modified bleeding index, keratinized mucosa width, and mucosal thickness were recorded at the permanent restoration and the postoperative first year. Horizontal bone level and vertical bone level were assessed with cone beam computed tomography images taken before the surgery and one year after prosthesis insertion. The pink esthetic score was evaluated with intraoral photographs taken before the surgical procedure and first-year follow-up.

Detailed Description

This study aimed to compare the non-grafted socket shield technique with simultaneously guided bone regeneration in immediate implant placement in terms of clinical, esthetic, and radiographic parameters. Within the scope, immediate implant placement was applied to randomized groups (socket shield technique and guided bone regeneration). Immediate implant placement was performed following shield preparation in the shield group, and guided bone regeneration was applied in the regeneration group. A temporary non-functional immediate prosthesis was inserted at the same visit. After four months, permanent restorations were applied. Clinical, radiographic, and esthetic parameters were compared between two groups at baseline and first-year follow-up.

Conditions

Immediate Implant Placement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Socket shield technique with immediate implant placement

For the patients in the shield group, shields were prepared with the Root Membrane Kit. After the palatal part was removed, the buccal fragment was prepared at the crest level, and an internal bevel chamfer was formed on the fragment. Implants were placed 3-4 mm apical to the gingival margin of the adjacent teeth.

Group Type: EXPERIMENTAL

Socket shield technique

Intervention Type: PROCEDURE

For the patients in the shield group, shields were prepared with the Root Membrane Kit. After the palatal part was removed, the buccal fragment was prepared at the crest level, and an internal bevel chamfer was formed on the fragment. Implants were placed 3-4 mm apical to the gingival margin of the adjacent teeth. Healing caps were placed, and the periphery of the caps was covered with an absorbable gelatin sponge.

Guided bone regeneration with immediate implant placement

For the patients in the regeneration group, teeth were extracted atraumatically, implants were placed 3-4 mm to the gingival margin, and the space between the implant and buccal bone was filled with anorganic bovine bone graft at the time of implant placement. The graft particles were covered by a pericardium membrane. The membrane was fixed to the bone with titanium pins.

Group Type: EXPERIMENTAL

Guided bone regeneration

Intervention Type: PROCEDURE

For the patients in the regeneration group, teeth were extracted atraumatically, implants were placed 3-4 mm to the gingival margin, and the space between the implant and buccal bone was filled with anorganic bovine bone graft at the time of implant placement. The graft particles were covered by a pericardium membrane. The membrane was fixed to the bone with titanium pins.

Interventions

Socket shield technique

For the patients in the shield group, shields were prepared with the Root Membrane Kit. After the palatal part was removed, the buccal fragment was prepared at the crest level, and an internal bevel chamfer was formed on the fragment. Implants were placed 3-4 mm apical to the gingival margin of the adjacent teeth. Healing caps were placed, and the periphery of the caps was covered with an absorbable gelatin sponge.

Intervention Type: PROCEDURE

Guided bone regeneration

For the patients in the regeneration group, teeth were extracted atraumatically, implants were placed 3-4 mm to the gingival margin, and the space between the implant and buccal bone was filled with anorganic bovine bone graft at the time of implant placement. The graft particles were covered by a pericardium membrane. The membrane was fixed to the bone with titanium pins.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with the health status of American Society of Anesthesiologists class I or II,
• Nonsmokers,
• Unrestorable single-rooted tooth in the maxillary esthetic region,
• Periodontally healthy, non-mobile teeth,
• Single implant placement,
• Minimum 3-5 mm available vertical bone apical to the apex,
• Intact socket wall after extraction.

Exclusion Criteria

• Medically compromised patients, especially uncontrolled diabetes,
• Psychiatric problems,
• Pregnancy, lactation, or suspicion of pregnancy,
• A history of radiation therapy to the head and neck region or immunosuppressive therapy,
• Metabolic bone disorder or the presence of drugs known to affect bone metabolism,
• Poor plaque control,
• Vertical root fracture on the buccal surface or a horizontal fracture below the bone level,
• External or internal resorption affecting the buccal part of the root,
• Acute infection in the area intended for implant placement,
• Refusal to attend follow-up appointments.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kutahya Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Ezgi Gürbüz

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ezgi Ceylan, PhD

Role: PRINCIPAL_INVESTIGATOR

Kutahya Health Sciences University

Locations

Kutahya Health Sciences University

Kütahya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

0044

Identifier Type: -

Identifier Source: org_study_id