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

Samer Faraj

Status: Completed

Conditions: Ridge Deficiency

Treatments: Procedure: Guided Bone Regeneration (GBR)

Study type: Interventional

Funder types: Other

Identifiers

NCT03290638

13-0540-F3R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Dehydrated Human Amnion Chorion Membrane

Experimental group

Description:

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.

Treatment:

Procedure: Guided Bone Regeneration (GBR)

Type I Bovine Collagen Membrane

Active Comparator group

Description:

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.

Treatment:

Procedure: Guided Bone Regeneration (GBR)