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

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

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).

Study Overview

• Status: Completed
• Conditions: Peri-implant Mucositis
• Intervention / Treatment: 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

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Catania, Italy, 95124
    • AOU Policlinico G. Rodolico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of probing depth at implant sites	Probing depth changes	3-months

Collaborators and Investigators

• Sponsor: University of Catania
• Investigators: Principal Investigator: Gaetano Isola, Università degli Studi di Catania

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): July 25, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: December 26, 2022
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis
• Other Study ID Numbers: 150/2679/2022/PO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Results and clinical protocol
• IPD Sharing Time Frame: 6-months
• IPD Sharing Access Criteria: Official university website/pubmed
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No