Clinical trial NCT05990283: Socket Shield Technique and Guided Bone Regeneration
Official title: Comparison of Non-grafted Socket Shield Technique With Guided Bone Regeneration in Immediate Implant Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immediate Implant Placement
Keywords: bone regeneration
dental implant
esthetics
grafts
socket shield technique
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Peri-implant probing depth
timeFrame: Four months after implant restoration and first-year follow-up
measure: Modified plaque index
timeFrame: Four months after implant restoration and first-year follow-up
measure: Modified bleeding index
timeFrame: Four months after implant restoration and first-year follow-up
measure: Keratinized mucosa width
timeFrame: Four months after implant restoration and first-year follow-up
measure: Mucosal thickness
timeFrame: Four months after implant restoration and first-year follow-up
measure: Radiographic bone level in the horizontal dimension
timeFrame: Before implant surgery and first year follow-up
measure: Radiographic bone level in the vertical dimension
timeFrame: Before implant surgery and first year follow-up
measure: Pink esthetic score
timeFrame: Before implant surgery and first year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Sciences University
Study officials:
affiliation: Kutahya Health Sciences University
name: Ezgi Ceylan, PhD
role: PRINCIPAL_INVESTIGATOR
References: