Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2019
Source Kutahya Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04992416 - Immediately Placed Implants Using Simvastatin and Autogenous Tooth Graft Combination in Periodontally Compromised Sites N/A
Active, not recruiting NCT05670067 - Alveolar Ridge and Soft Tissue Augmentation Using Graft From the Maxillary Tuberosity N/A
Withdrawn NCT06038695 - Immediate Implant Placement Using Volume-Stable Collagen Matrix Combined With rhPDGF-BB N/A
Recruiting NCT05436158 - The Use of a New Safe Angle Position for Implant Placement in the Anterior Region.
Not yet recruiting NCT06246253 - Bone Formed Labial to the Implant in Relation to the Horizontal Gap Dimension in Immediate Implant Placement.
Not yet recruiting NCT06207565 - Immediate Implant Placement Utilizing Vestibular Flap Versus Single Flap Approach With Bone Graft N/A
Enrolling by invitation NCT05330702 - Ultrasound-based Imaging to Detect Early Changes of Hard and Soft Tissue Around Immediately Placed Implants With or Without Soft Tissue Augmentation N/A
Enrolling by invitation NCT05880771 - Immediate Implant Placement: a Clinical and Radiographic Study on Hard and Soft Tissues Retraction at One Year. N/A
Completed NCT04795102 - Effect of "Autogenous Leukocyte Platelet Rich Fibrin- Tooth Graft" Combination Around Immediately Placed Implants N/A
Completed NCT03422458 - The Impact of Immediate Implant Placement on Alveolar Ridge Preservation Techniques N/A
Completed NCT04803500 - Simvastatin Around Immediate Implant Phase 2