Ridge Preservation With Putty Allografts

NCT03956251 | Completed

• 1 other identifier: 19.0516
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Loss

Outcome Measures

Primary Outcomes (1)

• Change in horizontal width from post-extraction site to 4-month.

  Horizontal post-extraction ridge measurements at the mid-defect alveolar crest and 5 mm apical taken with a caliper.

  0 and 16 weeks

Secondary Outcomes (3)

• Change in post extraction ridge height.

  0 and 16 weeks

• Change in facial soft tissue thickness and final occlusal soft tissue thickness.

  0 and 16 weeks

• Histologic composition. (Histologic percent vital bone, nonvital bone and trabecular space.

  16 weeks

Study Arms (2)

Combined Mineralized/Demineralized Putty Allograft

EXPERIMENTAL

Ridge preservation with a Mineralized/Demineralized Putty allograft

Procedure: Combined Mineralized/Demineralized Putty Allograft

Demineralized Putty Allograft

ACTIVE COMPARATOR

Ridge preservation with Demineralized Putty allograft

Procedure: Demineralized Putty Allograft

Interventions

Combined Mineralized/Demineralized Putty Allograft PROCEDURE

At time of extraction, 15 test patients will receive ridge preservation using Combined Mineralized/Demineralized Putty Allograft

Combined Mineralized/Demineralized Putty Allograft

Demineralized Putty Allograft PROCEDURE

At time of extraction, 15 control patients will receive ridge preservation using Demineralized Putty Allograft

Demineralized Putty Allograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Healthy male or female who is at least 18 years old.
• Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

You may not qualify if:

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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

Graduate Periodontics, UofL School of Dentistry

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Henry Greenwell, DMD MSc

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director, Graduate Periodontics

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 20, 2019
• Study Start: August 29, 2019
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: June 3, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)