Impact of Oral Hygiene Instructions in the Resolution of Peri-implant Mucositis

NCT06535958 | Completed

• 1 other identifier: PER-ECL-2023-07
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Peri-implant mucositis (PM) over dental implants is a highly prevalent disease characterized by inflammation of the peri-implant mucosa without loss of supporting bone around implants. If untreated, PM may progress into peri-implantitis, which may ultimately lead to implant loss. Multiple clinical studies have described a cause-effect relationship between the accumulation of biofilm and the development of PM and therefore effective oral hygiene practices and professional biofilm control are fundamental in their prevention and management. As it was stated in the latest expert consensus on the prevention and treatment of peri-implant diseases, up to date, the treatment of PM includes mechanical professional cleaning associated with oral hygiene instructions (OHI). However, the impact of OHI by itself is not known. This randomized clinical trial over 56 patients aims to identify if there is any superiority of individualized OHI and mechanical/physical instrumentation over OHI alone. The main objective is to evaluate the resolution of the disease, by means of reduction of modified bleeding index (mBI) 1 and 3 months after treatment. Secondary objectives include evaluating microbiological changes and determining if the extent of inflammation measured as the initial mBI could have any impact on PM resolution after different treatment modalities.In addition, the hypotheses formulated are as follows;

• The proper oral hygiene measures conducted by the patient after individualized OHI will achieve resolution of PM in a clinically relevant proportion of patients.
• The proper oral hygiene measures conducted by the patient after individualized OHI will reduce the expression of peri-implant pathogens as much as the combination of individualized OHI and professional mechanical debridement in a clinically relevant proportion of patients.
• The proper oral hygiene measures conducted by the patient after individualized OHI will reduce mBI as much as the combination of individualized OHI and professional mechanical debridement in a clinically relevant proportion of patients.
• The extent of inflammation measured as the mBI could be related with the degree of resolution of the disease according to the treatment.

Conditions

Peri-implant Mucositis

Outcome Measures

Primary Outcomes (1)

• Modified bleeding index

  An electronic pressure-calibrated probe is used. The index is measured tooth by tooth, and later averaged. The minimum value is 0 and the maximum value is 3, with the best value being 0 and the worst value being 3.

  At baseline, 1 and 3 months after treatment

Secondary Outcomes (6)

• Full mouth plaque Index

  At baseline, 1 and 3 months after treatment

• Full mouth bleeding index

  At baseline, 1 and 3 months after treatment

• Full mouth probing pocket depth

  At baseline, 1 and 3 months after treatment

• Suppuration on probing

  At baseline, 1 and 3 months after treatment

• Implant probing pocket depth

  At baseline, 1 and 3 months after treatment

Study Arms (2)

Test group (OHI)

EXPERIMENTAL

Behavioral: OHI

Control Group (OHI+PMPR)

EXPERIMENTAL

Behavioral: OHI; Procedure: OHI+PMPR

Interventions

OHI BEHAVIORAL

All patients (test and control) will be instructed to brush the implants twice daily to remove supragingival biofilms with a low-abrasive dentifrice and to use specific cylindrical or conical brushes in the interproximal area. Patients will be indicated to brush under, around, and in the peri-implant crevice circumferentially. In those cases with no access for proper OHI, prosthesis will be modified.The interproximal brush device used will be chosen for the patient individually, according to the interproximal space available, the thicker brush that can be used comfortably will be the selected one. It will be previously tested on the patient and its use will be taught, patients should demonstrate proficiency

Control Group (OHI+PMPR); Test group (OHI)

OHI+PMPR PROCEDURE

Supra- and sub-gingival debridement of the implant surface, the implant neck, and the abutment will be carried out by means of a combination of ultrasonics with a plastic tip and plastic curettes . Finally, the prosthetic components will be polished with a rubber cup

Control Group (OHI+PMPR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of, at least, one titanium implant that have been more than one year in function and exhibits PM, defined as bleeding on gentle probing (0.20 N) in at least one peri-implant site.
• No signs of loss of supporting bone after initial bone remodelling. In cases where baseline radiograph is available, it will be used for comparison, otherwise a maximum of 2 mm of crestal bone loss will be accepted
• Presence of \>1 mm of keratinized peri-implant mucosa.
• Absence of systemic diseases that could influence the outcome of the therapy (i.e. controlled diabetes, with HbA1c\<7, patients will be included).
• Non-smoker or light smoking status in smokers (\<10 cigarettes/day)

You may not qualify if:

• Untreated periodontal conditions.
• Pregnant or lactating women.
• Patients who received systemic antibiotics in the last 3 months.
• Patients who received treatment of PM in the past 3 months.
• Patients receiving corticoids or medications known to have effect on gingival growth (i.e., calcium channel antagonists, immunosuppressants or antiepileptic drugs)

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Barcelona, Sant Cugat Del Vallès, 08195, Spain

Location

Study Officials

• Beatriz de Tapia Pastor, DDS,MSC,PhD

  Universitat Internacional de Catalunya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, Department of Periodontology, Universitat Internacional de Catalunya (UIC)

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: September 16, 2024
• Primary Completion: January 9, 2025
• Study Completion: April 9, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

ES (1)