NCT02697890

Effect of Mucograft® Seal on Post-extraction Ridge Preservation Using Bone Allograft

Effect of Mucograft® Seal on Post-extraction Ridge Preservation Using Bone Allograft: A Randomized Controlled Clinical Trial and Radiographic Evaluation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Tufts University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate clinically and radiographically the effect of Mucograft® seal when used for the ridge preservation procedure in combination with Freeze Dried Bone Allograft (FDBA) at the extraction site in terms of hard and soft tissue remodeling after 4 months healing period.

Detailed description

One of the serious consequences of single or multiple tooth extraction is the bone resorption that follows, which may create aesthetic problems and compromise future implant placement. Ridge preservation procedures typically use a combination of a scaffold and a membrane. Scaffolds most commonly used are bone grafts; autogenous, allografts, xenografts, and alloplasts. Among these bone grafts, allograft materials such as Demineralized Freeze Dried Bone Allograft (DFDBA) and Freeze Dried Bone Allograft (FDBA) are frequently used in site preservation procedures. An additional alternative is to use a collagen sponge (CS) in the extraction socket to prevent the infiltration of soft tissues to the lower area and to protect and maintain bone graft materials. Although ridge preservation has several benefits, it also has several risks and limitations, such as membrane exposure and possible infection, loss or fibrous encapsulation of graft particles, longer healing period prior to implant placement, invasive and technique sensitive procedure, additional cost, and possible soft tissue dehiscence in bone grafted sites compared with non-grafted sites. Therefore, any modifications of the technique that will reduce these risks and limitations would be advantageous. Mucograft® TM has been specifically designed for soft-tissue regeneration. Its bi-layer structure supports tissue in-growth and regeneration and promotes cellular and extracellular integration within the host tissue. Clinically, this new collagen membrane was associated with a sufficient width of newly formed attached gingiva with coverage of Miller class-I and class-II recession defects. These results suggest that the use of Mucograft® TM in periodontal plastic surgery may provide a viable source of grafting material as an alternative to autogenous and non-autogenous soft tissue graft materials. This study is a clinical and radiographic, randomized parallel arm comparative evaluation of the addition of Mucograft® seal to FDBA in the ridge preservation procedure. Group A will receive FDBA and a CS. Group B will receive FDBA with Mucograft® seal.

Conditions

• Tooth Extraction Status Nos

Interventions

Type	Name	Description
DEVICE	FDBA (MinerOss®) + Mucograft® seal	Collagen matrix membrane for soft-tissue regeneration
DEVICE	FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®)	Standard of Care

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-03-03
• Last updated: 2020-03-31
• Results posted: 2017-05-16