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

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.

Study Overview

• Status: Recruiting
• Conditions: Edentulous Alveolar Ridge
• Intervention / Treatment: Procedure: Soft tissue augmentation with subepithelial connective tissue graft (SCTG); Procedure: Soft tissue augmentation with xenogenic volume stable collagen matrix

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy
    • Recruiting
    • University of Turin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Subepithelial Connective Tissue Graft (SCTG); 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); 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.
EXPERIMENTAL: Volume Stable Collagen Matrix (VCMX); Soft tissue augmentation at edentulous area with xenogenic volume stable collagen matrix	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Probing Pocket Depth (PD) at adjacent teeth (0-15 mm with higher values representing worse outcomes)	The distance between cementoenamel junction (CEJ) and the base of the pocket	6 months
Mucosal recession at adjacent sites (0-15 mm with higher values indicating worse outcomes)	The distance between the cementoenamel junction (CEJ) and the mucosal margin	6 months
Pain (VAS scale)(0-10 with higher values indicating worse outcomes)	Subjective pain experienced by the patient expressed in a VAS scale	2 weeks

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 10, 2021
• Primary Completion (ANTICIPATED): June 10, 2023
• Study Completion (ANTICIPATED): March 10, 2024

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 31, 2021
• First Posted (ACTUAL): June 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: GFGTurin1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No