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Immediate implant placement with alveolar ridge preservation or partial root retention: a randomized controlled clinical trial assessing biological long-term complications, three-dimensional ridge alterations and patient-reported outcome measures

Immediate implant placement with alveolar ridge preservation or partial root retention: a randomized controlled clinical trial assessing biological long-term complications, three-dimensional ridge alterations and patient-reported outcome measures - SST

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00014324
Enrollment
40
Registered
2018-03-26
Start date
2018-06-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with a hopeless tooth in need of single tooth implant replacement between canine and canine in the upper jaw. None

Interventions

Group 1: Subsequent to tooth extraction a cylindrical screw-type dental implant will be inserted (SPI Element®
Thommen Medical, Grenchen, Switzerland). Deproteinized bovine bone mineral (Bio-Oss® Spongiosa 0.25-1 mm
Geistlich, Wolhusen, Switzerland) will be moistened with sterile water and packed in the space between implant and extraction socket. Subsequent a collagen membrane (BioGide®
Geistlich, Wolhusen, Switzerland) will be plugged around the implant to cover and protect the bone substitute material. Group 2: After completion of the drilling protocol the coronal half of the faci
Thommen Medical, Grenchen, Switzerland) exerting as little pressure on the root segment as possible.

Sponsors

Gemeinschaftspraxis
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Male and female, systemically healthy patients, at least 18 years of age, presenting hopeless teeth in need of single tooth implant replacement between canine and canine in the upper jaw - Periodontally healthy conditions including the ability to achieve good oral hygiene and control gingivitis with FMPS and FMBS = 25% (full-mouth plaque (FMPS) and bleeding (FMBS) scores) - No medication known to interfere with periodontal tissue health or healing. - No pregnancy - Ability to understand study procedures and to comply with them for the entire duration of the study. Ability and willingness to give written informed consent

Exclusion criteria

Exclusion criteria: - Presence of less than 50% of a hypothetically idealised buccal bone height relative to the vertical distance between the base of the extraction socket and the midpalatal alveolar bone margin extension based on digital cone beam computed tomography (CBCT) measurements. - Patients smoking more than 20 cigarettes per day - Participation in another clinical trial

Design outcomes

Primary

MeasureTime frame
Non-inferiority of test versus control surgical intervention with respect to loss in marginal bone level after 1y post-implantation assessed on standardized periapical radiographs

Secondary

MeasureTime frame
- Clinical assessment of plaque and bleeding, height of keratinized tissue, probing pocket depth (using dental probe and standard forms) - Ridge contour changes (based on dental impressions) - Pink esthetic score (based on photographs) - Patient Reported Outcome Measures (PROMs) (based on standardized surveys)

Countries

Brazil

Contacts

Public ContactGiuseppe Alexandre Romito

University of São Paulo, School of Dentistry, Discipline of Periodontics, Department of Stomatology

garomito@usp.br+55 11 3091-7868

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026