Skip to content

Comparison of clinical and radiographical outcomes following placement of hybrid and moderate rough implants in the posterior mandible of periodontally compromised patients: a 3-year randomized clinical trial

Comparison of clinical and radiographical outcomes following placement of hybrid and moderate rough implants in the posterior mandible of periodontally compromised patients: a 3-year randomized clinical trial - Comparison of hybrid and rough implants in perio patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50613
Enrollment
43
Registered
2020-02-27
Start date
2020-09-17
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

dental implant bone loss Dental implant inflammation

Interventions

Surgical procedure: " All surgeries are performed under local anaesthesia. " After a crestal incision and intrasulcular incision at the adjacent teeth, a buccal and lingual full-thickness mucoperiost

Sponsors

Vrije Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Periodontally compromised patients having a history of proximal attachment loss of > 5mm in > 30% of teeth present - Enrolled in a supportive periodontal therapy (SPT) program after active periodontal treatment - Requirement of two single-unit FPDs supported by two implants in mandibular premolar/molar area - Adjacent tooth/teeth must have natural root(s) - In antagonist jaw natural teeth, partial prosthesis, or implants supported (partial) prosthesis in contact with planned FPD - History of edentulism in planned implant areas > 4 months - At planned implant areas, a minimum of 11 mm bone in vertical dimension and minimum of 6 mm in horizontal dimension available. Assessment included CBCT scan when required, judged by investigator - Acquiring of a primary stable implant situation assumed by investigator

Exclusion criteria

Exclusion criteria: - History of local radiotherapy to the head and neck region - History of chemotherapy 10 cigarettes a day - Uncontrolled diabetes mellitus - Known or suspected current malignancy - Pregnancy at time of inclusion - Alcohol or drug abuse - Any systemic or local disease that would compromise postoperative healing and/or osseointegration - Need for systemic bisphosphonates, corticosteroids or any other medication that would compromise postoperative healing and/or osseointegration - Presence of active clinical periodontal disease expressed by probing pocket depths > 5 mm and bleeding on probing - History of necrotic or rapid progressive periodontitis - Untreated caries and/or endodontic disease - Previous implant loss - Previous bone augmentation in planned implant area - Incapability of performing oral hygiene measures as a result of physical or mental disorders - During any period of the study, if any mandatory procedures and measurements are missing by the investigator, that dataset of that subject will be removed from the final results.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is the radiographical implant mean marginal bone level (MBL) alteration on the mesial and the distal site 36 months after delivery of the FPDs.

Secondary

MeasureTime frame
Secondary outcomes are implant survival, implant stability, marginal peri-implant soft tissue conditions (amount of plaque, bleeding on probing and pocket probing depths) and peri-implant microbiological compilation.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)