Isolated Premolar Edentulous Site Clinical Trial
— ETPEI-RCTOfficial title:
Evaluation of Morphological and Dimensional Alveolar Bone Changes Around Post-extraction Implants in an Open Flap, Open Flap and Grafting and Flapless Technique. A Clinical Randomized Controlled Study
NCT number | NCT03001752 |
Other study ID # | 4987 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | November 2018 |
Verified date | January 2019 |
Source | University of Bari |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a three-armed randomized controlled clinical trial aiming the estimation of dimensional alveolar bone changes after insertion of post-extraction implants through 3 different surgical techniques: open flap, open flap and grafting, flapless.
Status | Completed |
Enrollment | 45 |
Est. completion date | November 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility |
Inclusion Criteria: - absence of any systemic disease that might compromise implant integration or wound healing - appropriate periodontal health (measured through periodontal indexes) - presence of premolars with indications of extractions, presence of adjacent teeth - absence of fenestrations - presence of vestibular alveolar wall with a minimum of 0.5mm of thickness Exclusion Criteria: - patients who have undergone CT scanning in the past 5 years - heavy smokers (more than 20 cigarettes per day) - patients not showing up at 1 and 3 months hygiene sessions - patients not showing up at 6 months follow-up |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Bari |
Lee CT, Chiu TS, Chuang SK, Tarnow D, Stoupel J. Alterations of the bone dimension following immediate implant placement into extraction socket: systematic review and meta-analysis. J Clin Periodontol. 2014 Sep;41(9):914-26. doi: 10.1111/jcpe.12276. Epub — View Citation
Tarnow DP, Chu SJ. Human histologic verification of osseointegration of an immediate implant placed into a fresh extraction socket with excessive gap distance without primary flap closure, graft, or membrane: a case report. Int J Periodontics Restorative — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Marginal Bone Loss measured through CT Cone Beam | Difference of marginal bone level measured immediately after treatment and 6 months after on two repeated (immediately after and 6 months after implant insertion) CT Cone Beam | 6 months | |
Primary | Alveolar Bone Dimensional Reduction assessed through CT Cone Beam | Three-dimensional Alveolar Bone Reduction (horizontal and vertical) will be measured on two repeated (immediately after and 6 months after implant insertion) on CT Cone Beam, having as reference points the implant platform and the implant apex. | 6 months | |
Secondary | Pain and Discomfort measured through questionaire | Pain and discomfort experienced by the patient after the surgery, measured through a VAS scale on a questionaire | 1 Week | |
Secondary | Intra-operatory or post-operatory complications assessed through intra-operatory observation and post-intervention check-ups. | Intra-operatory or post-operatory intervention-related adverse events such as excessive bleeding, swallowing, hematoma will be recorded for each patient. | 6 months | |
Secondary | Time needed to perform surgical intervention | Time needed to perform surgical intervention (immediately after tooth extraction until finishing of surgical procedure) will be recorded for each intervention. | 1-2 hours |