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NCT04915677
Edentulous Sites Augmented With Collagen Matrix or CTG
NA trial testing Soft tissue augmentation with subepithelial connective tissue graft (SCTG) in Edentulous Alveolar Ridge in 28 participants. Status unknown.
10 June 2023
Quick facts
| Lead sponsor | University of Turin, Italy |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 28 |
| Start date | 10 June 2021 |
| Primary completion | 10 June 2023 |
| Estimated completion | 10 March 2024 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Soft tissue augmentation with subepithelial connective tissue graft (SCTG)
- Soft tissue augmentation with xenogenic volume stable collagen matrix
Conditions studied
- Edentulous Alveolar Ridge — all drugs for Edentulous Alveolar Ridge →
Sponsor
University of Turin, Italy
Who can join
18 and older, any sex, with Edentulous Alveolar Ridge. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04915677
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Soft tissue augmentation with subepithelial connective tissue graft (SCTG)
Trials testing the same drug.
- NCT05466006 — Peri-implant Soft Tissue Volume Changes at Small Buccal Dehiscences · NA · unknown
Other recruiting trials for Edentulous Alveolar Ridge
Currently open trials in the same condition.
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- NCT06449443 — Zero Echo Time MR for the Assessment of Maxillary Sinus and Dental Regions · recruiting
- NCT06678945 — Using Two Different Attachments in Mandibular Implant Overdenture Cases in Order to Retention and Patient Satisfaction · NA · active not recruiting
Other University of Turin, Italy trials
Trials by the same sponsor.
- NCT06493188 — Low VS High-fidelity Interprofessional Simulation for ABG Skills Acquisition · NA · not yet recruiting
- NCT07418489 — Biotics Intervention Oriented to Rescue From Environmental Pollution Inflammatory Responses · NA · enrolling by invitation
- NCT07311291 — The Effect of Different Hemostatic Agents on Hemorrhage Control, Pain and Quality of Life After Endodontic Microsurgery. · NA · completed
- NCT06904963 — Efficacy of Oral Hygiene Instructions Carried Out Using an Intra-oral Scanner · NA · completed
- NCT07047261 — Efficacy of a Xanthan-based Chlorhexidine Gel in the Treatment of Peri-implant Mucositis · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04915677 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Turin, Italy
- Last refreshed: 13 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04915677.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing