Edentulous Sites Augmented With Collagen Matrix or CTG

NCT ID: NCT04915677

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-10
• Study Completion Date: 2024-03-10

Brief 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

Study Design

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

Study Groups

Subepithelial Connective Tissue Graft (SCTG)

Soft tissue augmentation at edentulous area with subepithelial connective tissue graft harvested from the patient's palate

Group Type: ACTIVE_COMPARATOR

Soft tissue augmentation with subepithelial connective tissue graft (SCTG)

Intervention Type: PROCEDURE

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.

Volume Stable Collagen Matrix (VCMX)

Soft tissue augmentation at edentulous area with xenogenic volume stable collagen matrix

Group Type: EXPERIMENTAL

Soft tissue augmentation with xenogenic volume stable collagen matrix

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Intercalated mono-edentulous area ridge defects to be rehabilitated with fixed partial bridge
• At least 18 years old
• At least 6 months from tooth extraction at the study area.

Exclusion Criteria

• Systemic diseases which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus);
• Smoking ≥ 10 cigarettes a day;
• Pregnant or nursing women;
• Chronic use of corticosteroids or other anti-inflammatory or immune-modulator drugs;
• Patients who need use of medications affecting bone metabolism or oral mucosa;
• Presence of a congruous FDP at the edentulous area;
• History of soft tissue augmentation surgery in the study area;
• Active periodontitis
• Uncompliant patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Turin

Turin, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Mario Aimetti

Role: CONTACT

mario.aimetti@unito.it

00390116331546

Facility Contacts

Giacomo Baima, DDS

Role: primary

giacomo.baima@unito.it

00393497254708

Other Identifiers

GFGTurin1

Identifier Type: -

Identifier Source: org_study_id