Long- Term Follow-up of Extraction Socket Management

NCT03410251 | Completed

• 1 other identifier: H2016-2 ExMA5
• Study Type: observational
• Target: 17
• Locations: 0 countries
• Sites: N/A

Brief Summary

Twenty-nine patients needing single tooth replacement in aesthetic area were treated by extraction and socket preservation with saddle connective tissue graft between September 2009 and February 2012. Computed Tomography scan were taken at baseline just after the surgery and 3 months later. Long- term evaluation of this particular socket management procedure was evaluated by recalling successfully seventeen of theses patients in June 2016. At this time, a clinical and radiographical consultation was done and Cone Beam CT was taken. Horizontal and vertical bone dimensional changes were then assessed thanks to 3D imaging analysis and esthetic and implants outcomes were evaluated.

Conditions

Tooth Loss

Outcome Measures

Primary Outcomes (2)

• Changes from Baseline Alveolar bone remodeling to 3 months and 6 year: horizontal measurements (based on CBCT, in mm)

  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.

  Baseline, 3 months, 6 years

• Changes from Baseline Alveolar bone remodeling to 3 months and 6 year : vertical measurements (based on CBCT, in mm)

  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.

  Baseline, 3 months, 6 years

Secondary Outcomes (4)

• Esthetic outcomes (PES questionnaire)

  Approximatively 6 years

• Esthetic outcomes (VAS questionnaire)

  Approximatively 6 years

• Implant survival rate (based on criteria of Buser et al., 1990)

  Approximatively 6 years

• Peri-implant bone levels (based on periapical radiography, in mm)

  Approximatively 6 years

Interventions

Socket preservation PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were recruited from the Department of Periodontology and Oral Surgery of the University of Liège, Belgium.

You may qualify if:

• Good general health (ASA 1, 2)
• Controlled periodontitis
• \>18 years of age or signed consent by the parents
• Smoking history of\<10 cigarettes per day
• Signed informed consent.

You may not qualify if:

• Pregnancy or lactation
• Concurrent participation in another trial
• Bone disease or the use of medications that interfered with bone metabolism
• History of head and neck radio- therapy
• Presence of dehiscence or fenestration on bone wall of the socket.

Sponsors & Collaborators

• University of Liege: lead

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: January 25, 2018
• Study Start: June 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2017
• Last Updated: January 25, 2018

Record last verified: 2018-01