Treatment of Post-Extraction Dehisced Socket - A Case Series Study (OSTEO2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02980211|
Recruitment Status : Completed
First Posted : December 2, 2016
Last Update Posted : January 3, 2019
PURPOSE The purpose of this case series is to clinically, radiographically and histologically evaluate the treatment of dehiscence defects in extraction sockets using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane.
METHODS Subjects with single-rooted teeth indicated for extraction and interested in future implant therapy for tooth replacement will be recruited on the basis of an eligibility criteria. A buccal or lingual dehiscence defect must strongly be suspected or confirmed upon clinical examination in order for the subject to qualify for study inclusion. A cone-beam computer tomography (CBCT) scan of the arch containing the tooth to be extracted will be obtained prior to tooth extraction. Following minimally invasive tooth extraction and debridement, the socket will be evaluated to verify the presence of a dehiscence defect affecting at least 50% of the bony plate height. After creating a soft tissue 'pouch' using tunneling instruments, a non-absorbable dense-PTFE (dPTFE) barrier membrane that will be trimmed to a size and shape that would allow for complete extension over the existing defect will be tucked between the mucosa and the alveolar bone. Then, the extraction socket will be grafted with particulate allograft and the access to the socket will be sealed with an extension of the membrane and an external cross mattress suture. Subjects will be recalled at 1, 2 and 5 weeks to monitor healing and assess the level of discomfort using a visual analog scale at the end of each visit. At the 5-week visit, the membrane will be gently removed and the exposed area will be left to heal by secondary intention. At 20 weeks after tooth extraction a second CBCT will be obtained to radiographically evaluate the site for implant placement. Bone volumetric reconstructions of the alveolar ridge at baseline and at 20 weeks will be made using the CBCT data to assess changes affecting the bone housing. If the site has healed adequately, implant placement will be planned at 24 weeks after tooth extraction. A bone core biopsy will be obtained at the time of implant placement in order to histologically analyze the characteristics of the grafted substrate. Upon implant placement with primary stability a healing abutment will be placed and sutures will be given to achieve primary wound closure, as necessary. Subjects will return for the final study visit at 2 weeks following implant placement to evaluate the healing prior to being referred back to the restorative dentist.
|Condition or disease||Intervention/treatment||Phase|
|Tooth Loss||Device: Ridge Reconstruction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical, Radiographic and Histologic Evaluation of a Novel Alveolar Ridge Reconstruction Approach in Post-Extraction Dehiscence Defects: A Case Series Study|
|Actual Study Start Date :||March 1, 2017|
|Actual Primary Completion Date :||May 3, 2018|
|Actual Study Completion Date :||May 17, 2018|
Experimental: Tooth Extraction and Graft Dehisced Socket
Treatment of dehiscence defects at the time of tooth extraction using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane.
Device: Ridge Reconstruction
Tooth extraction will be attempted in minimally traumatic, flapless, fashion. Following tooth extraction, the existence of the suspected dehiscence defect will be confirmed; absence of a defect will result in subject exclusion from the study and the case will be considered an intent-to-treat. Horizontal and vertical dimensions of the defect will be measured using a UNC-15 probe. After creating a soft tissue 'pouch' using tunneling instruments, a non-absorbable dense-PTFE (dPTFE) [Cytoplast TXT-200, Osteogenics Biomedical] barrier membrane, trimmed to the size and shape that would allow for complete extension over the existing defect, will be tucked between the mucosa and the alveolar bone. The socket will then be grafted using a particulate bone allograft [EnCore, Osteogenics Biomedical] and the socket access will be sealed with an extension of the dPTFE membrane to ensure complete coverage of the bone graft and the crestal bone.
- Volumetric changes [ Time Frame: 20 weeks post-extraction ]Alveolar bone volumetric changes using CBCT scans
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980211
|United States, Iowa|
|University of Iowa College of Dentistry - Craniofacial Clinical Research Program|
|Iowa City, Iowa, United States, 52242|