Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes for Guided Bone Regeneration

NCT03290638 | Completed

• 1 other identifier: 13-0540-F3R
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this randomized clinical study was to evaluate the use of dehydrated human amnion-chorion membrane as an exposed barrier for guided bone regeneration (GBR) after tooth extraction and to determine whether intentional exposure of this membrane to the oral environment compromises ridge dimensions and bone vitality for implant placement.

Conditions

Ridge Deficiency

Keywords

Guided Bone Regeneration; Dehydrated Human Amnion Chorion Membrane; Type I Bovine Collagen Membrane; Ridge Preservation; Ridge Healing; Teeth Extraction

Outcome Measures

Primary Outcomes (2)

• Alveolar Ridge Dimensional Changes

  Clinical ridge height changes were taken with a thermoplastic triad stent, and a University of North Carolina (UNC) 15 periodontal probe. Ridge width changes measurements were taken with a metal bone caliper. Alveolar ridge dimensional changes in height and width were measured at the times of extraction and at the time of implant placement.

  Alveolar Ridge Dimensional Changes were taken at the extraction time and at the time of implant placement. Mean = 19.5 weeks

• Alveolar Ridge Bone Vitality

  a core bone biopsy specimen 2 mm in diameter was obtained from the center of the root at the time of implant placement for histomorphometric analyses

  Mean= 19.5 weeks after tooth extraction and bone grafting

Secondary Outcomes (1)

• Ridge Healing Evaluation

  Two weeks form the time of the extraction

Study Arms (2)

Dehydrated Human Amnion Chorion Membrane

EXPERIMENTAL

This membrane was investigated to evaluate its use as an open barrier for guided bone regeneration (GBR) after tooth extraction and to determine whether intentional exposure of this membrane to the oral environment compromises ridge dimensions and bone vitality for implant placement.

Procedure: Guided Bone Regeneration (GBR)

Type I Bovine Collagen Membrane

ACTIVE COMPARATOR

This membrane has been tested as an open barrier for GBR after tooth extraction. The intentional use of this membrane to the oral environment did not compromise ridge dimensions and bone vitality for implant placement.

Procedure: Guided Bone Regeneration (GBR)

Interventions

Guided Bone Regeneration (GBR) PROCEDURE

Teeth Extraction With Bone Grafting and Membrane

Also known as: Ridge Preservation

Dehydrated Human Amnion Chorion Membrane; Type I Bovine Collagen Membrane

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients included in the study were required:
• Not to be completely edentulous.
• To have at least 1 tooth that could not be saved and for which extraction and delayed implant placement were planned

You may not qualify if:

• Had received radiation therapy
• Were taking antiresorptive medication (i.e., bisphosphonate or denosumab)
• Had uncontrolled systemic disorders (such as uncontrolled diabetes, congestive heart failure, or acute odontogenic infections)
• Were smokers (more than 10 cigarettes per day)
• Were pregnant or breastfeeding.

Sponsors & Collaborators

• Samer Faraj: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 25, 2017
• Study Start: October 3, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: September 25, 2017

Record last verified: 2017-09