Clinical trial NCT02660697: 3D Radiographic Evaluation of a Novel Implant Site Development Technique
Official title: 3D Radiographic Evaluation of Post-extraction Healing Following Treatment With a Novel Implant Site Development Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tooth Extraction Status Nos
Edentulous Alveolar Ridge
Keywords: socket preservation, implant site development
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2016-01-21
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present retrospective study aims at assessing the clinical effects of a novel implant site development (Extraction site development - XSD) technique after tooth extraction compared with extraction alone in patients requiring dental implant placement following healing of extraction sockets.

Detailed description: In advanced (Extraction Defect Sounding Class 3-4) alveolar defects, a minimally invasive tunnelised socket preservation technique utilising long term resorbable membranes and connective tissue grafting was used for extraction site development (XSD). The novel technique was evaluated in a retrospective comparative case series study including a total of 54 extraction sites. In the test group, out of 33 single rooted teeth, 29 in the maxilla and 4 in the mandible were removed, extractions sites were treated by the XSD method. Out of 33 teeth, 27 were incisors, 2 canines and 4 premolars. In the control group, out of 21 single rooted teeth, 11 in the maxilla and 10 in the mandible were extracted and left for spontaneous healing. Out of 21 teeth, 13 were incisors, 2 canines and 6 premolars. CBCT scans were taken prior to tooth extraction and 6-9 months later in both groups. Radiographic evaluation was carried out using the I-CAT Vision (Imaging Sciences International, LLC; Hatfield, USA) and ImageJ (National Institutes of Health) softwares. Following manual alignment of CBCTs vertical and horizontal linear measurements as well as planimetric measurements of cross-section areas were performed in pre- and postoperative data sets at the extraction sites.

Eligibility criteria: Inclusion Criteria:

Presence of at least 1 single rooted tooth scheduled for extraction with EDS Class 3-4 type buccal bony dehiscence

Exclusion Criteria:

Exclusion criteria int he test group included uncontrolled inflammation at the surgical site, full mouth plaque or bleeding scores more than 20%, diabetes, pregnancy, known metabolic bone diseases, smoking more than 10 cigarettes a day, history of any relevant systemic diseases, radiotherapy chronic use of bisphosphonates or systemic steroids.

Primary outcomes:
measure: Orovestibular socket dimension
timeFrame: From baseline to 6-9 months postoperatively
Secondary outcomes:
measure: Minimal orovestibular socket dimension feasible for implant placement
timeFrame: From baseline to 6-9 months postoperatively
measure: Vertical socket dimension
timeFrame: From baseline to 6-9 months postoperatively
measure: Socket area
timeFrame: From baseline to 6-9 months postoperatively
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University Department of Periodontology
Study officials:
affiliation: Semmelweis University Department of Periodontology
name: Balint Molnar, DMD, PhD
role: PRINCIPAL_INVESTIGATOR
References: