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NCT04075383
Immediate and Early Single Dental Implants
Phase 2 trial testing immediate dental implant in Single Tooth Lost in 120 participants. Status unknown.
22 June 2024
Quick facts
| Lead sponsor | Federal University of Rio Grande do Sul |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 22 June 2019 |
| Primary completion | 22 June 2024 |
| Estimated completion | 22 June 2024 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- immediate dental implant
- immediate-delayed dental implant
Conditions studied
- Single Tooth Lost — all drugs for Single Tooth Lost →
- Dental Implant — all drugs for Dental Implant →
Sponsor
Federal University of Rio Grande do Sul
Who can join
Adults 18 to 65, any sex, with Single Tooth Lost or Dental Implant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of the research project will be to compare immediate and early unitary implants for the rehabilitation of missing teeth in the upper aesthetic region. A randomized controlled trial will be conducted in parallel with 120 individuals (60 per group) who are above 18 years of age, periodontally healthy, and who need to perform only one unit implant in the upper aesthetic region between the second premolars. In the immediate implant group, the tooth will be extracted in a minimally traumatic manner and the implant will be installed immediately after the fresh alveolus. Bovine bone replacement will be inserted into the gap between implant and vestibular wall of the alveolus, and an immediate temporary will be installed immediately. The provisional will be maintained for 3 months when the definitive crown will be made. In the early implant group, the tooth will be extracted, and after 2 months the implant will be installed with the use of bovine bone substitute to restore the buccal bone contour. The implant will be submerged, and 3 months of osseointegration will be performed reopening and final crown making. In both groups, the individuals will be followed for 1 year after the installation of the definitive crown. The outcomes evaluated will be patient satisfaction (main outcome), gingival phenotype, visible plaque, depth of probing, submucosal bleeding, proximal radiographic bone level, tomographic vestibular bone volume, perimplant clinical aesthetic indexes (Esthetic Pink Score and Papillary Index), evaluation three-dimensional tissue from intra-oral scanning and 3D printing, implant-related quality of life, and early and late implantation failures. Linear and logistic models of generalized estimating equations that take into account the longitudinal character of the study will be used for data analysis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
Other trials of immediate dental implant
Trials testing the same drug.
- NCT07199725 — Clinical and Radiographic Evaluation of Natural Bovine Bone With Hyaluronic Acid on Osseointegration of Immediate Implan · Phase 2, PHASE3 · completed
- NCT03691467 — the Effect of Topical Application of Hyaluronic Acid on Immediate Dental Implant · Phase 4 · completed
Other Federal University of Rio Grande do Sul 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 NCT04075383 (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 Federal University of Rio Grande do Sul
- Last refreshed: 5 April 2022
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/NCT04075383.
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