Socket Shield Technique and Guided Bone Regeneration

Immediate Implant Placement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05990283
• Other study ID #: 0044
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: January 20, 2023

Study information

• Verified date: November 2019
• Source: Kutahya Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 20, 2023
• Est. primary completion date: December 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immediate Implant Placement

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Kutahya Health Sciences University	Kutahya

Sponsors (1)

Lead Sponsor	Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peri-implant probing depth	Probing depth measured by Williams periodontal probe	Four months after implant restoration and first-year follow-up
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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