Ridge Preservation With Putty Allografts
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|ClinicalTrials.gov Identifier: NCT03956251|
Recruitment Status : Suspended (COVID)
First Posted : May 20, 2019
Last Update Posted : September 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tooth Loss||Procedure: Combined Mineralized/Demineralized Putty Allograft Procedure: Demineralized Putty Allograft||Not Applicable|
Thirty patients will be treated using the principles of guided bone regeneration utilizing a full thickness flap for ridge preservation. Fifteen test patients will receive an intrasocket demineralized and mineralized combination putty allograft (MinerOss Putty, BioHorizons) covered with a regenerative tissue matrix membrane (AlloDerm GBR, BioHorizons). The positive control group of fifteen patients will receive an intrasocket demineralized putty allograft (Puros, Zimmer) covered with a regenerative tissue matrix membrane (AlloDerm GBR, BioHorizons). Approximately, four months post-surgery, a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing.
Prior to surgery, each patient will receive a diagnostic work-up including standardized radiographs (periapicals), study casts, clinical photographs, and a clinical examination to record attachment level, probing depth, recession, and mobility of teeth adjacent to the extracted sites. Customized acrylic occlusal stents will be fabricated on the study casts to serve as fixed reference guides for the measurements. Detailed oral hygiene instructions will be provided.
For histology, trephine core specimens will be evaluated to determine percent vital bone, non-vital bone, and trabecular space. Step serial sections will be taken from each longitudinally sectioned core. The sections will be stained with hematoxylin and eosin. Ten slides per patients will be prepared with at least 4 sections per slide. For each patient, 6 of 10 slides will be assessed. The mean percentage of vital and nonvital bone, and trabecular space will be determined for each patient.
Soft tissue thickness will be measured prior to the procedure. The surgical procedure will consist of a full-thickness papilla preservation flaps performed on the buccal and palatal/lingual to expose the alveolar ridge and the tooth to be extracted. Following the extraction, vertical measurements will be taken with the acrylic occlusal stent in place, and horizontal measurements with a specially designed digital caliper. Both groups will receive an intrasocket graft covered by a regenerative tissue matrix membrane. The control group will receive a demineralized putty allograft. The test group will receive a combination mineralized and demineralized putty allograft. The surgical procedures will be documented with clinical photographs of teeth and/or intraoral structures.
Post surgical management includes all patients will be seen every 2 weeks until 8 weeks post-surgery. Patients will then be seen monthly until month 4 for the final examination and trephine core collection for histological analysis and implant placement. Patients will take doxycycline 100 mg qd for two weeks, Hydrocodone/Acetaminophen 5/325mg q4-6h as needed for pain, and naproxen 375mg q12h for one week for inflammation reduction. Postoperative visits will consist of supragingival plaque removal, and oral hygiene reinforcement Any patient who develops any significant post-operative complications or adverse reaction to the materials used or shows attachment loss greater or equal to 2 mm on teeth adjacent to the experimental site will be exited from the study and will receive appropriate treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Ridge Preservation Comparing the Clinical and Histologic Healing of Two Different Putty Allografts|
|Actual Study Start Date :||August 29, 2019|
|Estimated Primary Completion Date :||May 1, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: Combined Mineralized/Demineralized Putty Allograft
Ridge preservation with a Mineralized/Demineralized Putty allograft
Procedure: Combined Mineralized/Demineralized Putty Allograft
At time of extraction, 15 test patients will receive ridge preservation using Combined Mineralized/Demineralized Putty Allograft
Active Comparator: Demineralized Putty Allograft
Ridge preservation with Demineralized Putty allograft
Procedure: Demineralized Putty Allograft
At time of extraction, 15 control patients will receive ridge preservation using Demineralized Putty Allograft
- Change in horizontal width from post-extraction site to 4-month. [ Time Frame: 0 and 16 weeks ]Horizontal post-extraction ridge measurements at the mid-defect alveolar crest and 5 mm apical taken with a caliper.
- Change in post extraction ridge height. [ Time Frame: 0 and 16 weeks ]
Vertical post-extraction ridge measurements from a stent.
- Mid socket osseous crest on facial and lingual
- Mesial and distal socket border - facial and lingual osseous crest.
- Change in facial soft tissue thickness and final occlusal soft tissue thickness. [ Time Frame: 0 and 16 weeks ]Soft tissue thickness measurements at the crest, 5mm apical, and mid-occlusal post treatment only taken with a #40 endodontic reamer.
- Histologic composition. (Histologic percent vital bone, nonvital bone and trabecular space. [ Time Frame: 16 weeks ]Obtain via trephine core
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): NCT03956251
|United States, Kentucky|
|Graduate Periodontics, UofL School of Dentistry|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Henry Greenwell, DMD MSc||University of Louisville|