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

Samer Faraj43 enrolled

Overview

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.

Forty-three patients requiring extraction of at least one tooth and delayed implant placement were randomly assigned to either an experimental or a control group. For both groups, demineralized freeze-dried bone allograft was used to graft the socket. For the control group, Type I bovine collagen was used as a membrane; for the experimental group, human amnion-chorion membrane was used. For both groups, the barrier membranes were left exposed, and no primary closure was achieved. Patients returned for implant placement after a mean healing period of 19.5 weeks, at which time a core bone biopsy specimen 2 mm in diameter was obtained for histomorphometric analyses. Clinical ridge dimensions were measured at the times of extraction and implant placement.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ridge Deficiency

Interventions

Guided Bone Regeneration (GBR)PROCEDURE

Teeth Extraction With Bone Grafting and Membrane

Eligibility

Sex: ALLMin age: 18 YearsMax age: 78 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: . 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 Exclusion Criteria: Patients were excluded if they : * 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.

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: Mean= 19.5 weeks after tooth extraction and bone grafting

Secondary Outcomes

Ridge Healing Evaluation

Pictures of the healing ridges were taken using clinical macro lens photography

Time frame: Two weeks form the time of the extraction

Data from ClinicalTrials.gov

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