Long- Term Follow-up of Extraction Socket Management
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|ClinicalTrials.gov Identifier: NCT03410251|
Recruitment Status : Completed
First Posted : January 25, 2018
Last Update Posted : January 25, 2018
|Condition or disease||Intervention/treatment|
|Tooth Loss||Procedure: Socket preservation|
|Study Type :||Observational|
|Actual Enrollment :||17 participants|
|Official Title:||Long- Term Follow-up of Extraction Socket Management : Clinical Outcomes and Hard Tissue Changes|
|Actual Study Start Date :||June 2016|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2017|
- Procedure: Socket preservation
Teeth were extracted atraumatically and without flap release in patients who have received prophylactic antibiotherapy and local anaesthesia. After checking the integrity of the buccal and palatal bone plate, biomaterial (Bio-Oss®) was introduced into the socket. A connective tissue graft harvested from the palate was inserted and sutured in buccal and palatal pouches in order to cover the socket.
chlorhexidine spray (0.12%) twice a day and Ibuprofen 600 mg three times/ day were prescribed whereas antibiotics were continued for 5 days. Tooth brushing was banned at the extraction site for 10 days and sutures were removed 10 days after surgery.
- Changes from Baseline Alveolar bone remodeling to 3 months and 6 year: horizontal measurements (based on CBCT, in mm) [ Time Frame: Baseline, 3 months, 6 years ]The measurement were done by matching and superimposing CT scans using a three dimensional reconstruction software. Palatal horizontal measurements were calculated by subtracting the buccal horizontal measurements from the total horizontal measurements.
- Changes from Baseline Alveolar bone remodeling to 3 months and 6 year : vertical measurements (based on CBCT, in mm) [ Time Frame: Baseline, 3 months, 6 years ]The measurement were done by matching and superimposing CT scans using a three dimensional reconstruction software. One vertical measurement was taken on the buccal side, in parallel to the vertical reference line at mid distance between the buccal wall and reference line.
- Esthetic outcomes (PES questionnaire) [ Time Frame: Approximatively 6 years ]At the cross- sectional long- term evaluation, to analyse the esthetic outcomes of the surgical procedure, the pink esthetic score (PES) was assessed (Fürhauser et al. 2005)
- Esthetic outcomes (VAS questionnaire) [ Time Frame: Approximatively 6 years ]A VAS questionnaire was given to the patients in order to collect their opinion about the esthetic results.
- Implant survival rate (based on criteria of Buser et al., 1990) [ Time Frame: Approximatively 6 years ]Success was defined according to the criteria of Buser et al., 1990 which are 1. absence of suppuration (recurring peri implant infection) 2. absence of persistent complaints like pain, foreign body sensation and/or dysesthesia 3. absence of continuous radioluncency area around the implant 4. absence of implant mobility.
- Peri-implant bone levels (based on periapical radiography, in mm) [ Time Frame: Approximatively 6 years ]The peri- implant bone levels were assessed on periapical radiography using the parallell technique: the distance between the implant shoulder and the first bone to implant contact (DIB) was measured at the mesial and distal aspects using the specific software Image J64 (National Institutes of Health, Bethesda, MD, USA).