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Completed

NCT Number: NCT03290638

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

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.

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Key information

Conditions

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guided Bone Regeneration (GBR)

Procedure

Teeth Extraction With Bone Grafting and Membrane

Other names: Ridge Preservation

Primary outcomes

  1. Alveolar Ridge Dimensional Changes

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

    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.

  2. Alveolar Ridge Bone Vitality

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

    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

Secondary outcomes

  1. Ridge Healing Evaluation

    Time frame: Two weeks form the time of the extraction

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

Sponsors and collaborators

Lead sponsor

Samer Faraj

Other

Registry information

Official study title

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

Acronym: GBR

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 25, 2017
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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