Mix of Demineralized Freeze-Dried Bone Allograft and Deproteinized Bovine Bone Mineral: a Possible Solution for Alveolar Ridge Preservation?

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNova Southeastern University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Alveolar ridge preservation

    Procedure/Surgery

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Test GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

changes in horizontal dimensions of the alveolar ridge

Soft and hard tissue horizontal dimensions of the alveolar ridge will be measured after extraction and 4 months later.

Time frame
4 months
2

changes in vertical dimensions of the alveolar ridge

Soft and hard tissue vertical dimensions of the alveolar ridge will be measured after extraction and 4 months later.

Time frame
4 months

Secondary outcomes

1

vital bone percentage

vital bone percentage will evaluated histologically following biopsy at time of implant placement.

Time frame
4 months

Other outcomes

1

thickness of the buccal plate in mm and its influence on the ridge dimension

the thickness of the buccal plate will be measured digitally to assess if it may be a confounding factor

Time frame
4 months
2

the thickness of the lingual plate in mm and its influence on the ridge dimension

the thickness of the lingual plate will be measured digitally to assess if it may be a confounding factor

Time frame
4 months
3

the thickness of the overlying buccal soft tissue in mm and its influence on the ridge dimension

the thickness of the overlying soft tissue will be measured digitally to assess if it may be a confounding factor

Time frame
4 months, 1 year
4

the position of extraction site (maxilla vs. mandible) and its influence on the ridge dimension

the position of the tooth in the arch will be analyzed to assess if it may be a confounding factor

Time frame
4 months, 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nova Southeastern University

Lead sponsor

Geistlich Pharma AG

Collaborator

ZimVie

Collaborator