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Impact of Smoking on the Effectiveness of Non Surgical Treatment of Peri-implant Mucositis

Primary Purpose

Peri-implant Mucositis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Non surgical peri-implant mucositis therapy with one-stage full-mouth scaling
Non surgical peri-implant mucositis therapy with one-stage full-mouth scaling and chlorexidine
Sponsored by
University of Catania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-implant Mucositis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: peri-implant mucositis bleeding on probing and/or a gingival index <1 at least at one site at baseline absence of peri-implant bone loss during the last 2 years before baseline Exclusion Criteria: Periodontal disease Systemic diseases

Sites / Locations

  • AOU Policlinico G. Rodolico

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

SRP and no chlorhexidine

SRP plus 0.12% chlorhexidine

Arm Description

Patients received a one-stage full-mouth scaling without chlorhexidine performed in one session of full mouth scaling and root planing.

Patients received a one-stage full-mouth scaling with 0.12% chlorhexidine performed in one session of full mouth scaling and root planing.

Outcomes

Primary Outcome Measures

Changes of probing depth at implant sites
Probing depth changes

Secondary Outcome Measures

Full Information

First Posted
December 26, 2022
Last Updated
July 25, 2023
Sponsor
University of Catania
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1. Study Identification

Unique Protocol Identification Number
NCT05711576
Brief Title
Impact of Smoking on the Effectiveness of Non Surgical Treatment of Peri-implant Mucositis
Official Title
Impact of Smoking at Baseline on the Effectiveness of Non Surgical Treatment of Peri-implant Mucositis: a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 27, 2022 (Actual)
Primary Completion Date
March 27, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the present study was to test the hypothesis that smoking impact non-surgical periodontal therapy results in a greater clinical improvement in patients with peri-implant mucositis.
Detailed Description
The aim of the present study was to test the hypothesis that the smoking levels at baseline influence full mouth disinfection results in a greater clinical and microbiological improvement compared with sole mechanical debridement within one session in patients with peri-implant mucositis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implant Mucositis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
After randomized assignment to a test and a control group, patients received a one-stage full-mouth scaling with or without chlorhexidine. Clinical and microbiological examination was performed at baseline, after 1, 3, and 6 months.
Masking
ParticipantInvestigator
Masking Description
Sealed envelopes
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SRP and no chlorhexidine
Arm Type
Placebo Comparator
Arm Description
Patients received a one-stage full-mouth scaling without chlorhexidine performed in one session of full mouth scaling and root planing.
Arm Title
SRP plus 0.12% chlorhexidine
Arm Type
Active Comparator
Arm Description
Patients received a one-stage full-mouth scaling with 0.12% chlorhexidine performed in one session of full mouth scaling and root planing.
Intervention Type
Other
Intervention Name(s)
Non surgical peri-implant mucositis therapy with one-stage full-mouth scaling
Intervention Description
Patients were treated with full mouth non surgical peri-implant mucositis therapy performed with only full mouth scaling and root planing
Intervention Type
Other
Intervention Name(s)
Non surgical peri-implant mucositis therapy with one-stage full-mouth scaling and chlorexidine
Intervention Description
Patients were treated with full mouth non surgical peri-implant mucositis therapy performed with only full mouth scaling and root planing and chlorexidine
Primary Outcome Measure Information:
Title
Changes of probing depth at implant sites
Description
Probing depth changes
Time Frame
3-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: peri-implant mucositis bleeding on probing and/or a gingival index <1 at least at one site at baseline absence of peri-implant bone loss during the last 2 years before baseline Exclusion Criteria: Periodontal disease Systemic diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Isola
Organizational Affiliation
Università degli Studi di Catania
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOU Policlinico G. Rodolico
City
Catania
ZIP/Postal Code
95124
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Results and clinical protocol
IPD Sharing Time Frame
6-months
IPD Sharing Access Criteria
Official university website/pubmed

Learn more about this trial

Impact of Smoking on the Effectiveness of Non Surgical Treatment of Peri-implant Mucositis

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