An interventional study of Socket shield technique and Guided bone regeneration in Immediate Implant Placement, sponsored by Kutahya Health Sciences University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-18.
Sponsored by Kutahya Health Sciences University · Not applicable, Interventional, and Treatment
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.
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.
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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 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 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.
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.
Peri-implant probing depth
Probing depth measured by Williams periodontal probe
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Before implant surgery and first year follow-up
Plan to share: No
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Ran from Nov 2019 to primary completion in Dec 2021, 25 months.
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