Non Surgical Peri-implant Mucositis Treatment in Patients With Tissue-level and Bone-level Implants
NCT ID: NCT04751565
Last Updated: 2023-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2021-02-01
2021-12-20
Brief Summary
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Detailed Description
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Group B: Peri-implant mucositis (PM) bone-level (BL) implants after non-surgical mechanical debridement.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Tissue level implant Group
Evaluation of healing of peri-implant mucositis after non-surgical supra and subgingival debridement in patients with tissue level implant
Primary outcome
The primary outcome will be based on probing depth (PD)
Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy
Statistically significant different in terms of Bleeding on Probing will be recorded between groups.
Bone level implant Group
Evaluation of healing of peri-implant mucositis after non-surgical supra and subgingival debridement in patients with bone level implant
Primary outcome
The primary outcome will be the change in Bleeding on Probing (BOP) (Lang, Joss, Orsanic, Gusberti, Siegrist, 1986).
Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy
Statistically significant different in terms of Bleeding on Probing will be recorded between groups.
Interventions
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Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy
Statistically significant different in terms of Bleeding on Probing will be recorded between groups.
Eligibility Criteria
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Inclusion Criteria
* TL and BL titanium implants with smooth necks supporting cemented or screw-retained single-unit crowns diagnosed with PM (Berglundh, et al.,2018)
* Implants placed in both arches
* Patients with gingivitis or treated periodontitis (i.e., absence of residual PD \> 5 mm)
* Presence of at least 2 mm of keratinized mucosa at implant sites.
Exclusion Criteria
* regular use of anti-inflammatory drugs or antibiotics within 3 months prior to study enrollment
* Presence of systemic diseases
* Pregnant and lactating females
* Smokers \> 10 cigarettes/day
* Use of inflammatory drugs or antibiotics within 3 months prior to study recruitment
* Implants with modified (i.e. micro-rough) necks
* Interproximal open contacts between implant restoration and adjacent teeth
* Peri-implantitis (Renvert, et al., 2018)
25 Years
70 Years
ALL
Yes
Sponsors
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University of Messina
OTHER
Responsible Party
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Gaetano Isola, DDS, PhD
Researcher
Principal Investigators
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Gaetano Isola
Role: PRINCIPAL_INVESTIGATOR
Università degli Studi di Mesina
Locations
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University of Messina
Messina, , Italy
Countries
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Other Identifiers
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2021-18/18
Identifier Type: -
Identifier Source: org_study_id
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