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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

Recruiting
Conditions
dental implant bone loss
Dental implant inflammation
10041297
Registration Number
NL-OMON50613
Lead Sponsor
Vrije Universiteit
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
43
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

- History of local radiotherapy to the head and neck region
- History of chemotherapy < 5 years prior to surgery
- Smoking > 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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