Socket Shield Technique and Guided Bone Regeneration

Not Applicable

Completed

• Conditions: Immediate Implant Placement
• Interventions: Procedure: Socket shield technique; Procedure: Guided bone regeneration

• Registration Number: NCT05990283
• Lead Sponsor: Kutahya Health Sciences University

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.

Study Timeline

• Status Verified: 2019-11
• Study Start: 2019-11-01
• Primary Completion: 2021-12-27
• Study Completion: 2023-01-20
• Study First Submitted: 2023-07-29
• Study First Submitted QC: 2023-08-05
• Study First Posted: 2023-08-14
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Socket shield technique with immediate implant placement	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.
Guided bone regeneration with immediate implant placement	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.

Primary Outcome Measures

Name	Time	Method
Mucosal thickness	Four months after implant restoration and first-year follow-up	The thickness measured at 1.5 mm from the margin by the endodontic spreader
Keratinized mucosa width	Four months after implant restoration and first-year follow-up	The distance from the peri-implant mucosa margin to the mucogingival junction
Modified bleeding index	Four months after implant restoration and first-year follow-up	An index evaluated by the Williams periodontal probe indicates a minimum of 0 and a maximum of 3, with higher values indicating a worse outcome
Radiographic bone level in the vertical dimension	Before implant surgery and first year follow-up	Vertical bone level measured at cone beam computed tomography images
Peri-implant probing depth	Four months after implant restoration and first-year follow-up	Probing depth measured by Williams periodontal probe
Radiographic bone level in the horizontal dimension	Before implant surgery and first year follow-up	Horizontal bone level measured at cone beam computed tomography images
Modified plaque index	Four months after implant restoration and first-year follow-up	An index evaluated by the Williams periodontal probe indicates a minimum of 0 and a maximum of 3, with higher values indicating a worse outcome
Pink esthetic score	Before implant surgery and first year follow-up	A score as assessed by intraoral photographs, showing a minimum of 0 and a maximum of 14, with higher values indicating a better esthetic result

Trial Locations

Locations (1)

Kutahya Health Sciences University; 🇹🇷 Kutahya, Turkey