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NCT06250621
Manual or Digitally Guided Surgical Technique for Replacing Single Tooth Edentulism by Means of Sub-crestally Placed Implants. A 3-year Parallel Randomized Clinical Study on Marginal Bone Levels Stability
NA trial testing Implant placement in Dental Implant in 18 participants. Completed in 20 October 2023.
15 May 2021
Quick facts
| Lead sponsor | ASST Santi Paolo e Carlo |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 10 January 2020 |
| Primary completion | 15 May 2021 |
| Estimated completion | 20 October 2023 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Implant placement
Conditions studied
- Dental Implant — all drugs for Dental Implant →
- Marginal Bone Loss — all drugs for Marginal Bone Loss →
- Peri Implant Health — all drugs for Peri Implant Health →
- Supral Tissue Height — all drugs for Supral Tissue Height →
Sponsor
ASST Santi Paolo e Carlo
Who can join
Adults 18 to 70, any sex, with Dental Implant or Marginal Bone Loss. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the present prospective study was to investigate after a 2-year of follow-up any influence of the surgical technique, manual or digitally guided, on peri-implant marginal bone levels stability in implants placed 1 mm sub-crestally. Patients were treated by means of platform-switched implants provided with a 5 degrees internal conical connection and supporting single screw-retained fixed crowns. Marginal bone level (MBL) measured at prosthesis installation (t0) at 1 (t1), 2 (t2) and at 3 years of follow-up visit (t3) were considered. MBL change from t0 to t3 was investigated. The distance between the implant neck and the first radiographically detected bone to implant contact was considered to evaluate the bone loss. Two groups were considered: Test Group (GD) for implant sites treated with a digitally guided surgery procedure. Control Group (FH) for implants surgically placed without digitally guided surgery, respectively. All the procedures were performed by an experienced operator. Additionally, for both groups MBL changes were correlated to different supra-crestal soft tissue height (STH) amounts: less than 3 and ≥ 3 millimeters, respectively. Peri-implant soft tissue parameters such as probing depth (PPD), modified Sulcus Bleeding Index (mBI) and modified Plaque Index (mPI), were assessed for all the restorations included.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06250621
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Other ASST Santi Paolo e Carlo trials
Trials by the same sponsor.
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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 NCT06250621 (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 ASST Santi Paolo e Carlo
- Last refreshed: 9 February 2024
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/NCT06250621.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing