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

Peri-implant Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05711576
• Other study ID #: 150/2679/2022/PO
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: July 30, 2023

Study information

• Verified date: April 2024
• Source: University of Catania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the resolution of naturally occurring peri-implant mucositis (PM) treated by means of non-surgical mechanical debridement (NSMD) with or without full-mouth disinfection approach (FMD).

Description:

Fifty-six patients with 85 Implants affected by PM were randomly assigned to test (NSMD+FMD) or control procedures (NSMD + placebo). At baseline, 1, 3, 6 months, full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), probing depth (PD), bleeding on probing (BOP), modified gingival index (mGI), and modified plaque index (mPlI) were assessed. Furthermore, the proportions of Aggregatibacter Actynomycencomitans, Porphyromonas Gingivalis, Tannerella Forsythia and Treponema Denticola were also recorded. The BOP change was set as the primary outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 30, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• age =18 years old;
• smokers and non-smokers;
• implants with smooth necks supporting cemented or screw-retained single-unit crowns with at least one BOP-positive site (Berglundh et al., 2018)
• implants placed in both maxilla and mandible;
• patients with gingivitis or treated periodontitis with the absence of residual PD =5 mm;
• presence at least of 2 mm of keratinized mucosa at implant sites.

Exclusion Criteria:

• presence of systemic diseases;
• pregnancy or lactating;
• 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 (Berglundh et al., 2018)

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis

Intervention

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
• 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

Locations

Country	Name	City	State
Italy	AOU Policlinico G. Rodolico	Catania

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of probing depth at implant sites	Probing depth changes	3-months