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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05922527
Other study ID # PERIO2:5:1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date August 20, 2022

Study information

Verified date August 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date August 20, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Combined regenerative technique
Periodontal regenerative technique using amnion chorion membrane combined with DFDBA in a putty form
Open flap debridement
Open flap debridement

Locations

Country Name City State
Egypt Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical attachment level gain clinical attachment level gain intragroup and intergroup, measured clinically in mm using periodontal probe 6 months
Secondary Probing Pocket Depth Change Probing pocket depth change, measured clinically in mm using periodontal probe 6 months
Secondary Bone defect area bone defect area, measured radiographically in mm3 using periapical radiographs 6 months
See also
  Status Clinical Trial Phase
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Completed NCT04786327 - Minimally Invasive Flap With Platelet Rich Fibrin or Growth Factor Enhanced Matrix in Treatment of Intrabony Defect Phase 2
Completed NCT03611920 - Effect of Topical Tetracycline and Dexamethasone on Periodontal and Pulpal Regeneration of Replanted Avulsed Teeth