Edentulous Sites Augmented With Collagen Matrix or CTG

NCT04915677 | Unknown

• 1 other identifier: GFGTurin1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Volumetric buccal soft tissue changes (-5 to +5 mm with positive values representing an increase in volume)

  Mean linear change in mm from baseline to 6 months follow-up

  6 months

Secondary Outcomes (3)

• Change in Probing Pocket Depth (PD) at adjacent teeth (0-15 mm with higher values representing worse outcomes)

  6 months

• Mucosal recession at adjacent sites (0-15 mm with higher values indicating worse outcomes)

  6 months

• Pain (VAS scale)(0-10 with higher values indicating worse outcomes)

  2 weeks

Study Arms (2)

Subepithelial Connective Tissue Graft (SCTG)

ACTIVE COMPARATOR

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

Procedure: Soft tissue augmentation with subepithelial connective tissue graft (SCTG)

Volume Stable Collagen Matrix (VCMX)

EXPERIMENTAL

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

Procedure: Soft tissue augmentation with xenogenic volume stable collagen matrix

Interventions

Soft tissue augmentation with subepithelial connective tissue graft (SCTG) 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.

Subepithelial Connective Tissue Graft (SCTG)

Soft tissue augmentation with xenogenic volume stable collagen matrix 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.

Volume Stable Collagen Matrix (VCMX)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

University of Turin

Turin, Italy

RECRUITING

Central Study Contacts

Mario Aimetti

CONTACT

00390116331546; mario.aimetti@unito.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 7, 2021
• Study Start: June 10, 2021
• Primary Completion: June 10, 2023
• Study Completion: March 10, 2024
• Last Updated: February 13, 2023

Record last verified: 2023-02

Locations

IT (1)