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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
Sponsor:
Information provided by (Responsible Party):
Henry Greenwell, University of Louisville

Brief Summary:
The study will consist of randomized controlled clinical study trial comparing the results of a demineralized putty allorgraft versus a combined mineralized/demineralized putty allograft in approximately 30 patients, 15 per group. All materials used in the study are FDA approved.

Condition or disease Intervention/treatment Phase
Tooth Loss Procedure: Combined Mineralized/Demineralized Putty Allograft Procedure: Demineralized Putty Allograft Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Histologic composition. (Histologic percent vital bone, nonvital bone and trabecular space. [ Time Frame: 16 weeks ]
    Obtain via trephine core



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
  2. Healthy male or female who is at least 18 years old.
  3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

  1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
  2. Presence or history of osteonecrosis of jaws.
  3. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
  4. Patients who have been treated with oral bisphosphonates for more than three years.
  5. Patients with an allergy to any material or medication used in the study.
  6. Patients who need prophylactic antibiotics
  7. Previous head and neck radiation therapy.
  8. Chemotherapy in the previous 12 months.
  9. Patients on long term NSAID or steroid therapy.
  10. Pregnant or lactating patients.

Information from the National Library of Medicine

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


Locations
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United States, Kentucky
Graduate Periodontics, UofL School of Dentistry
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
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Principal Investigator: Henry Greenwell, DMD MSc University of Louisville
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Responsible Party: Henry Greenwell, Professor, Director, Graduate Periodontics, University of Louisville
ClinicalTrials.gov Identifier: NCT03956251    
Other Study ID Numbers: 19.0516
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases