Impact of Oral Hygiene Instructions in the Resolution of Peri-implant Mucositis
NCT Number: NCT06535958
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Peri-implant Mucositis
Interventions: BEHAVIORAL: OHI|PROCEDURE: OHI+PMPR
Sponsor: Universitat Internacional de Catalunya
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 56
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-16
Completion Date: 2025-03-01

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.

Primary Outcome Measures: 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 Outcome Measures: Full mouth plaque Index, A periodontal probe is used. Assessed dichotomously at four sites per tooth (mesial, buccal, distal, and lingual); 1 meaning presence of plaque and 0 abscense. This index is measured by the percentage of sites with plaque over the total number of sites evaluated., At baseline, 1 and 3 months after treatment|Full mouth bleeding index, Electronic pressure-calibrated probe. Assessed dichotomously as presence or absence of bleeding after 30 seconds of gently probing.1 meaning presence of blood and 0 abscense This index is measured by the percentage of sites bleeding over the total number of sites evaluated., At baseline, 1 and 3 months after treatment|Full mouth probing pocket depth, Electronic pressure-calibrated probe. Measured at six sites around each tooth, except third molars. Is used to measure the millimeters that the probe is introduced through the gingival sulcus., At baseline, 1 and 3 months after treatment|Suppuration on probing, Electronic pressure-calibrated probe. Assessed dichotomously as presence or absence of suppuration within 30 seconds after probing. 1 meaning presence of suppuration and 0 abcense, At baseline, 1 and 3 months after treatment|Implant probing pocket depth, Electronic pressure-calibrated probe. This index is used to know the millimeters that the probe is introduced through the peri-implant sulcus., At baseline, 1 and 3 months after treatment|Microbiological test, Sterile paper points. Detect the absence or presence of certain types of bacteria, At baseline, 1 and 3 months after treatment.