Immediate Implant Placement Clinical Trial
Official title:
Comparison of Non-grafted Socket Shield Technique With Guided Bone Regeneration in Immediate Implant Placement
NCT number | NCT05990283 |
Other study ID # | 0044 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 1, 2019 |
Est. completion date | January 20, 2023 |
Verified date | November 2019 |
Source | Kutahya Health Sciences University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Kutahya Health Sciences University | Kutahya |
Lead Sponsor | Collaborator |
---|---|
Kutahya Health Sciences University |
Turkey,
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 |
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