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Socket Shield Technique and Guided Bone Regeneration

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05990283
Enrollment
24
Registered
2023-08-14
Start date
2019-11-01
Completion date
2023-01-20
Last updated
2023-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immediate Implant Placement

Keywords

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

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.

Interventions

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.

PROCEDUREGuided 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.

Sponsors

Kutahya Health Sciences University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Peri-implant probing depthFour months after implant restoration and first-year follow-upProbing depth measured by Williams periodontal probe
Modified plaque indexFour months after implant restoration and first-year follow-upAn index evaluated by the Williams periodontal probe indicates a minimum of 0 and a maximum of 3, with higher values indicating a worse outcome
Modified bleeding indexFour months after implant restoration and first-year follow-upAn index evaluated by the Williams periodontal probe indicates a minimum of 0 and a maximum of 3, with higher values indicating a worse outcome
Keratinized mucosa widthFour months after implant restoration and first-year follow-upThe distance from the peri-implant mucosa margin to the mucogingival junction
Mucosal thicknessFour months after implant restoration and first-year follow-upThe thickness measured at 1.5 mm from the margin by the endodontic spreader
Radiographic bone level in the horizontal dimensionBefore implant surgery and first year follow-upHorizontal bone level measured at cone beam computed tomography images
Radiographic bone level in the vertical dimensionBefore implant surgery and first year follow-upVertical bone level measured at cone beam computed tomography images
Pink esthetic scoreBefore implant surgery and first year follow-upA score as assessed by intraoral photographs, showing a minimum of 0 and a maximum of 14, with higher values indicating a better esthetic result

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026