Skip to content

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

Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes for Guided Bone Regeneration (Socket Augmentation) : A Clinical and Histological Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03290638
Acronym
GBR
Enrollment
43
Registered
2017-09-25
Start date
2013-10-03
Completion date
2016-10-01
Last updated
2017-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ridge Deficiency

Keywords

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

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.

Detailed description

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.

Interventions

Teeth Extraction With Bone Grafting and Membrane

Sponsors

Samer Faraj
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Alveolar Ridge Dimensional ChangesAlveolar Ridge Dimensional Changes were taken at the extraction time and at the time of implant placement. Mean = 19.5 weeksClinical 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 Bone VitalityMean= 19.5 weeks after tooth extraction and bone graftinga 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

Secondary

MeasureTime frameDescription
Ridge Healing EvaluationTwo weeks form the time of the extractionPictures of the healing ridges were taken using clinical macro lens photography

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026