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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-12-20

Brief Summary

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This study is designed to compare the resolution of inflammation of naturally-occurring peri-implant mucositis (PM) at tissue-level (TL) and bone-level (BL) implants after non-surgical mechanical debridement.

Detailed Description

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Group A: Peri-implant mucositis (PM) at tissue-level (TL) implants after non-surgical mechanical debridement.

Group B: Peri-implant mucositis (PM) bone-level (BL) implants after non-surgical mechanical debridement.

Conditions

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Peri-implant Mucositis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Compare resolution of inflammation of naturally-occurring peri-implant mucositis (PM) at tissue-level (TL) and bone-level (BL) implants after non-surgical mechanical debridement.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

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)

Group Type EXPERIMENTAL

Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy

Intervention Type OTHER

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).

Group Type EXPERIMENTAL

Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male and female aged \> 18 years
* 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

* presence of medical conditions contraindicating treatment of peri-implant mucositis,
* 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)
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Messina

OTHER

Sponsor Role lead

Responsible Party

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Gaetano Isola, DDS, PhD

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Italy

Other Identifiers

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2021-18/18

Identifier Type: -

Identifier Source: org_study_id

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