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

Sponsor

University of Catania (Other)

Overall Status

Recruiting

CT.gov ID

NCT05711576

Collaborator

(none)

Enrollment

Location

Arms

3.1

Anticipated Duration (Months)

18.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Peri-implant Mucositis	Other: Non surgical peri-implant mucositis therapy with one-stage full-mouth scaling Other: Non surgical peri-implant mucositis therapy with one-stage full-mouth scaling and chlorexidine	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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, 2, and 3 months.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, 2, and 3 months.

Masking:

Double (Participant, Investigator)

Masking Description:

Sealed envelopes

Primary Purpose:

Treatment

Official Title:

Impact of Smoking at Baseline on the Effectiveness of Non Surgical Treatment of Peri-implant Mucositis: a Randomized Controlled Clinical Trial

Actual Study Start Date :

Dec 27, 2022

Anticipated Primary Completion Date :

Mar 27, 2023

Anticipated Study Completion Date :

Mar 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: SRP and no chlorhexidine Patients received a one-stage full-mouth scaling without chlorhexidine performed in one session of full mouth scaling and root planing.	Other: Non surgical peri-implant mucositis therapy with one-stage full-mouth scaling Patients were treated with full mouth non surgical peri-implant mucositis therapy performed with only full mouth scaling and root planing
Active Comparator: SRP plus 0.12% chlorhexidine Patients received a one-stage full-mouth scaling with 0.12% chlorhexidine performed in one session of full mouth scaling and root planing.	Other: Non surgical peri-implant mucositis therapy with one-stage full-mouth scaling and chlorexidine Patients were treated with full mouth non surgical peri-implant mucositis therapy performed with only full mouth scaling and root planing and chlorexidine

Arm

Intervention/Treatment

Placebo Comparator: SRP and no chlorhexidine

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

Other: Non surgical peri-implant mucositis therapy with one-stage full-mouth scaling

Patients were treated with full mouth non surgical peri-implant mucositis therapy performed with only full mouth scaling and root planing

Active Comparator: SRP plus 0.12% chlorhexidine

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

Other: Non surgical peri-implant mucositis therapy with one-stage full-mouth scaling and chlorexidine

Patients were treated with full mouth non surgical peri-implant mucositis therapy performed with only full mouth scaling and root planing and chlorexidine

Outcome Measures

Primary Outcome Measures

Changes of probing depth at implant sites [3-months]
Probing depth changes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOU Policlinico G. Rodolico	Catania		Italy	95124

Sponsors and Collaborators

University of Catania

Investigators

Principal Investigator: Gaetano Isola, Università degli Studi di Catania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gaetano Isola, Principal Investigator, University of Catania

ClinicalTrials.gov Identifier:

NCT05711576

Other Study ID Numbers:

150-22-PO

First Posted:

Feb 3, 2023

Last Update Posted:

Feb 3, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mucositis

Study Results

No Results Posted as of Feb 3, 2023