Amnion Chorion Membrane Combined With Allograft Bone Putty for the Management of Intrabony Defects

Clinical and Radiographic Evaluation of Using Amnion Chorion Membrane Combined With Allograft Bone Putty for the Management of Intrabony Defects in Patients With Chronic Periodontitis: a Randomized Clinical Trial

The ultimate goal for periodontal management is to obtain true periodontal regeneration. Periodontal regeneration implies that CAL gain is achieved through the formation of new cementum and new inserted periodontal ligaments, accompanied by alveolar bone formation, thus a whole new periodontal apparatus is reconstructed. Combined periodontal regenerative therapy; including bone grafting are considered a viable treatment option and result in significantly better clinical outcomes in intrabony defects compared to monotherapy.

This study was conducted as a randomized controlled clinical trial to evaluate clinically and radiographically the possible predictable results regarding the use of amnion chorion allograft (ACM) barrier and demineralized freeze dried bone allograft, (DFDBA) versus open flap debridement (OFD) in treatment of periodontal intrabony defects.

Study Overview

• Status: Completed
• Conditions: Periodontal Regeneration
• Intervention / Treatment: Procedure: Open flap debridement; Procedure: Combined regenerative technique

Detailed Description

True periodontal regeneration is the ultimate goal for periodontal management, implies that clinical attachment level gain is achieved through the formation of new cementum and new inserted periodontal ligaments, accompanied by alveolar bone formation, thus a whole new periodontal apparatus is reconstructed. Various techniques and biomaterials have been used to achieve periodontal regeneration of intraosseous defects.

In order to compare the effectiveness of various periodontal regenerative therapies in treating periodontal infrabony defects many systematic reviews were carried out. The use of guided tissue regeneration (GTR) and the combined therapies as regenerative approaches were shown to be more effective than flap procedures, nonetheless, the differences between regenerative therapies to be minor and insignificant.

Amnion chorion placental derived membrane (ACM) has been introduced in periodontal regenerative therapy owing to its biological properties. It is biocompatible, biodegradable and promotes proliferation and migration of the adjacent autogenous connective tissue. There is no single reported incidence of graft rejection, disease transmission or immune response from using placental tissues since its first documented usage till today. ACM has been used in many surgical dental procedures as GTR, alveolar bone preservation and guided bone regeneration. ACM possesses unique features that make it different from other materials used in this fields. In periodontal regenerative procedures as GTR, ACM assists rapid epithelial cell growth instead of epithelial cells exclusion as for the traditional concept of GTR. As epithelial cells are encouraged to migrate rapidly across the ACM barrier, they form an epithelial seal over the underlying bone graft or bony defect space and do not apically migrate into the defect .

Several studies support the use of ACM as an effective material alternative to the currently used materials/techniques for periodontal regeneration procedures, however more well conducted studies are still needed.

Accordingly, numerous data and researches are available nowadays, which support the great and variant regenerative capacities of the different periodontal biomaterials that are widely available and currently used for treatment of periodontal intra-bony defects, especially DFDBA and ACM. However, minimal radiographic findings were mentioned in the previous systematic reviews comparing combined regenerative approach and OFD.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Mature permanent tooth.
• Tooth with two or three-walled intra-bony defect, PPD ≥ 5mm with intra osseous defect ≥ 3mm.
• Good oral hygiene.
• Compliance with the maintenance program.
• Accepted the 6 months follow-up period.

Exclusion Criteria:

• Teeth with one wall intra-bony defect or supra-bony defects.
• Teeth with grade II or III mobility.
• Teeth with proximal carious defects or proximal faulty restorations.
• Medically compromised patients.
• Pregnant or nursing women.
• Smokers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined regenerative technique; Open flap debridement combined with Amnion Chorion Membrane and DFDBA	Procedure: Combined regenerative technique; Periodontal regenerative technique using amnion chorion membrane combined with DFDBA in a putty form
Active Comparator: Open flap debridement	Procedure: Open flap debridement; Open flap debridement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level gain	clinical attachment level gain intragroup and intergroup, measured clinically in mm using periodontal probe	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone defect area	bone defect area, measured radiographically in mm3 using periapical radiographs	6 months
Probing Pocket Depth Change	Probing pocket depth change, measured clinically in mm using periodontal probe	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): August 20, 2022

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: June 24, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 12, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PERIO2:5:1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No