NCT04915677

Edentulous Sites Augmented With Collagen Matrix or CTG

Volumetric Changes at Edentulous Sites Augmented With Collagen Matrix or Connective Tissue Graft: a Randomized Clinical Trial With 6 Months Follow up

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Ridge deformities can complicate prosthetic rehabilitation, especially in situations where optimal esthetic outcomes are desired. Simpler, less invasive and predictable treatments are needed in order to obtain soft tissue augmentation at edentulous ridges. Autogenous subepithelial connective tissue graft (SCTG) has always been regarded as the treatment of choice, but heterologous volume stable collagen matrix (VCMX) is emerging as a reliable alternative. The principal aim of the present RCT will be to compare the volumetric buccal soft tissue changes at edentulous areas after augmentation procedure using VCMX or SCTG. Parameters related to periodontal health at adjacent teeth and patient reported outcomes (PROMs) will be also assessed as secondary outcomes. Proving the non- inferiority of VCMX compared to SCTG would provide the specialists and general clinicians with an easier, less invasive and better tolerated technique for soft tissue augmentation at edentulous ridges and for improving aesthetic and cleansability of the prosthetic rehabilitation.

Conditions

• Edentulous Alveolar Ridge

Interventions

Type	Name	Description
PROCEDURE	Soft tissue augmentation with subepithelial connective tissue graft (SCTG)	After local anesthesia a mesio-distal crestal incision will be performed reaching the alveolar bone. Split thickness dissection performed both buccal and palatal. Subepithelial connective tissue graft will be harvested and inserted beneath the mucoperiosteal flap and stretched buccally and lingually using a modified horizontal mattress suture. The flap margins at the crest will be adapted using single interrupted sutures in order to achieve a primary closure of the flap.
PROCEDURE	Soft tissue augmentation with xenogenic volume stable collagen matrix	After local anesthesia a mesio-distal crestal incision will be performed reaching the alveolar bone. Split thickness dissection performed both buccal and palatal. Xenogenic volume stable collagen matrix will be inserted beneath the mucoperiosteal flap and stretched buccally and lingually using a modified horizontal mattress suture. The flap margins at the crest will be adapted using single interrupted sutures in order to achieve a primary closure of the flap.

Timeline

• Start date: 2021-06-10
• Primary completion: 2023-06-10
• Completion: 2024-03-10
• First posted: 2021-06-07
• Last updated: 2023-02-13

Locations

1 site across 1 country: Italy