Recruiting

Demineralized Allograft & Bovine Mineral

Sponsor:

Nova Southeastern University

Code:

NCT06275789

Conditions

Alveolar Ridge Preservation

Dental Extraction

Bone Graft

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Alveolar ridge preservation

Study Details

Brief summary:

The purpose of the study is to compare a new grafting material for alveolar ridge preservation to a commonly used and well studied material. Alveolar ridge dimensions as well as histology will be compared.

Conditions

Alveolar Ridge Preservation

Dental Extraction

Bone Graft

Study ID

NCT06275789

Start date

Jan 26, 2024

Status verified date

Sep, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients in good health
  • Require the extraction of at least one premolar or molar with future implant placement
  • Sufficient keratinized gingiva (equal or more than 2mm prior to extraction),
  • No more than 3mm of buccal bone loss
  • Flapless extraction possible
  • Full mouth plaque index of less than 25%

Exclusion Criteria:

  • Nicotine consumption equivalent to or more than 10 cigarettes per day
  • Electronic cigarette usage
  • A history of irradiation of head and neck area
  • Immunodeficiency disease
  • Uncontrolled systemic health problems (hypertension crisis 180/120, hyperthyroidism, diabetes with HbA1c over 7, recent history of stroke, cancer) History of medications that affect bone remodeling process (bisphosphonates, RANK-L inhibitors)
  • Previous adverse reaction to the biomaterials used
  • Pregnancy/lactation, or those who are trying to become pregnant.
  • Active uncontrolled or untreated periodontal disease
  • Periapical lesions greater than 1 cm and soft tissue pathology

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Test Group

This group will receive the grafting material that is a combination of DFDBA + DBBM + collagen matrix seal during the alveolar ridge preservation procedure.

active comparator: Control Group

This group will receive the grafting material that is a Tutoplast® processed mineralized particulate allograft + collagen matrix seal during the alveolar ridge preservation procedure.

Interventions

Alveolar ridge preservation

Premolar tooth will be extracted flapless and ridge preservation procedure with bone grafting material will be done.

Primary outcome measure

  • changes in horizontal dimensions of the alveolar ridge [ Time Frame: 4 months ]
  • changes in vertical dimensions of the alveolar ridge [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Andee Goldstein, DMD

7542599445ag3577@mynsu.nova.edu

Fatemeh Samavatijame, DMD

(734) 546-9018‬fs724@mynsu.nova.edu

Locations

Nova Southeastern University

Recruiting

Fort Lauderdale, Florida, United States, 33328

Contacts

Saynur Vardar-Sengul, DDS, PhD

954-262-1815svardarsengul@nova.edu

More Information

Sponsor

Nova Southeastern University

Last update posted

Sep 12, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nova Southeastern University on 2025-09-12.