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

Ridge Deficiency Clinical Trial

— GBR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03290638
• Other study ID #: 13-0540-F3R
• Status: Completed
• Phase: N/A
• First received: September 6, 2017
• Last updated: September 17, 2017
• Start date: October 3, 2013
• Est. completion date: October 1, 2016

Study information

• Verified date: September 2017
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 1, 2016
• Est. primary completion date: October 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dehydration
• Ridge Deficiency

Intervention

Procedure:
• Guided Bone Regeneration (GBR)
Teeth Extraction With Bone Grafting and Membrane

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samer Faraj

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Ridge Healing Evaluation	Pictures of the healing ridges were taken using clinical macro lens photography	Two weeks form the time of the extraction