Socket Shield Technique and Guided Bone Regeneration

NCT05990283 | Completed

• 1 other identifier: 0044
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Immediate Implant Placement

Keywords

bone regeneration; dental implant; esthetics; grafts; socket shield technique

Outcome Measures

Primary Outcomes (8)

• Peri-implant probing depth

  Probing depth measured by Williams periodontal probe

  Four months after implant restoration and first-year follow-up

• Modified plaque index

  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

  Four months after implant restoration and first-year follow-up

• Modified bleeding index

  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

  Four months after implant restoration and first-year follow-up

• Keratinized mucosa width

  The distance from the peri-implant mucosa margin to the mucogingival junction

  Four months after implant restoration and first-year follow-up

• Mucosal thickness

  The thickness measured at 1.5 mm from the margin by the endodontic spreader

  Four months after implant restoration and first-year follow-up

• Radiographic bone level in the horizontal dimension

  Horizontal bone level measured at cone beam computed tomography images

  Before implant surgery and first year follow-up

• Radiographic bone level in the vertical dimension

  Vertical bone level measured at cone beam computed tomography images

  Before implant surgery and first year follow-up

• Pink esthetic score

  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

  Before implant surgery and first year follow-up

Study Arms (2)

Socket shield technique with immediate implant placement

EXPERIMENTAL

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.

Procedure: Socket shield technique

Guided bone regeneration with immediate implant placement

EXPERIMENTAL

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.

Procedure: Guided bone regeneration

Interventions

Socket shield technique 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.

Socket shield technique with immediate implant placement

Guided bone regeneration 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.

Guided bone regeneration with immediate implant placement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University

Kütahya, 43100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics

Study Officials

• Ezgi Ceylan, PhD

  Kutahya Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 29, 2023
• First Posted: August 14, 2023
• Study Start: November 1, 2019
• Primary Completion: December 27, 2021
• Study Completion: January 20, 2023
• Last Updated: August 18, 2023

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)