Edentulous Alveolar Ridge Clinical Trial
Official title:
Volumetric Changes at Edentulous Sites Augmented With Collagen Matrix or Connective Tissue Graft: a Randomized Clinical Trial With 6 Months Follow up
NCT number | NCT04915677 |
Other study ID # | GFGTurin1 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 10, 2021 |
Est. completion date | March 10, 2024 |
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.
Status | Recruiting |
Enrollment | 28 |
Est. completion date | March 10, 2024 |
Est. primary completion date | June 10, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | University of Turin | Turin |
Lead Sponsor | Collaborator |
---|---|
University of Turin, Italy |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Pain (VAS scale)(0-10 with higher values indicating worse outcomes) | Subjective pain experienced by the patient expressed in a VAS scale | 2 weeks |
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