Socket Shield Technique and Guided Bone Regeneration

Comparison of Non-grafted Socket Shield Technique With Guided Bone Regeneration in Immediate Implant Placement

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.

Study Overview

• Status: Completed
• Conditions: Immediate Implant Placement
• Intervention / Treatment: Procedure: Socket shield technique; Procedure: Guided bone regeneration

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kutahya, Turkey, 43100
    • Kutahya Health Sciences University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-implant probing depth	Probing depth measured by Williams periodontal probe	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
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
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
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

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University
• Investigators: Principal Investigator: Ezgi Ceylan, PhD, Kutahya Health Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): December 27, 2021
• Study Completion (Actual): January 20, 2023

Study Registration Dates

• First Submitted: July 29, 2023
• First Submitted That Met QC Criteria: August 5, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: dental implant; grafts; bone regeneration; esthetics; socket shield technique
• Other Study ID Numbers: 0044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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