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

NCT ID: NCT05922527

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-08-20

Brief Summary

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.

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.

Conditions

Periodontal Regeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Combined regenerative technique

Open flap debridement combined with Amnion Chorion Membrane and DFDBA

Group Type: EXPERIMENTAL

Combined regenerative technique

Intervention Type: PROCEDURE

Periodontal regenerative technique using amnion chorion membrane combined with DFDBA in a putty form

Open flap debridement

Open flap debridement

Group Type: ACTIVE_COMPARATOR

Open flap debridement

Intervention Type: PROCEDURE

Open flap debridement

Interventions

Combined regenerative technique

Periodontal regenerative technique using amnion chorion membrane combined with DFDBA in a putty form

Intervention Type: PROCEDURE

Open flap debridement

Open flap debridement

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mariam Samy Abdelmalak Hanna

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

PERIO2:5:1

Identifier Type: -

Identifier Source: org_study_id