Evaluation of Amnion Chorion Membrane and Demineralized Bone Matrix Putty Allograft in Periodontal Intrabony Defects

Chronic Periodontitis Clinical Trial

Official title:

Clinical and Radiographic Evaluation of Amnion Chorion Membrane and Demineralized Bone Matrix Putty Allograft for Management of Periodontal Intrabony Defects: a Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02679209
• Other study ID #: Aminonchorion_DBM
• Status: Completed
• Phase: N/A
• First received: February 7, 2016
• Last updated: April 23, 2018
• Start date: June 2015
• Est. completion date: June 2017

Study information

• Verified date: April 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A clinical and radiographic evaluation of 2 regenerative techniques, bioresorbable membrane and bone allograft for management of periodontal intrabony defects.

Description:

Twenty-two patients suffering from advanced chronic periodontitis were included in this randomized controlled clinical trial. Each subject contributed had two- or three-walled intrabony defects. Patients were randomly assigned into two groups; bioresorbable membrane or bone allograft. Clinical parameters were recorded at baseline and at 3 and 6 months postoperatively. Radiographic parameters were recorded at baseline and at 6 months postoperatively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 50 Years

Eligibility

Inclusion Criteria:

• Severe chronic periodontitis patients.

• having at least one site with pocket depth = 6 mm and clinical attachment level = 5 mm, with radiographic evidence of bone loss as detected in periapical radiographs.

Exclusion Criteria:

• Pregnant women

• Having any given systemic disease

• Taking any type of medication and/or antibiotic therapy during the 3 months before the study

• Received periodontal treatment within the past 12 months Current or former smokers

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Biological:
• Demineralized bone matrix in putty form
it is a type of bone graft from human cadavers.
• Amnion chorion membrane
A bioresorbable allograft membrane for guided tissue regeneration from amnion and chorion parts of the placenta from pregnant females for guided tissue regeneration.

Locations

Country	Name	City	State
Egypt	Faculty of Oral and Dental Medicine, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Kothiwale SV, Anuroopa P, Gajiwala AL. A clinical and radiological evaluation of DFDBA with amniotic membrane versus bovine derived xenograft with amniotic membrane in human periodontal grade II furcation defects. Cell Tissue Bank. 2009 Nov;10(4):317-26. doi: 10.1007/s10561-009-9126-3. Epub 2009 Mar 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical attachment level	Change from baseline in clinical attachment level in mm in chronic periodontitis patients	change from Baseline at 6 months
Secondary	pocket depth	Estimation of pocket depth in mm in chronic periodontitis patients at baseline and 6 months	Baseline and 6 months
Secondary	bone defect area	Estimation of bone fill defect area in mm square in chronic periodontitis patients at baseline and 6 month	Baseline and 6 months