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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;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group (OHI) | Experimental |
| |
| Control Group (OHI+PMPR) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beatriz de Tapia Pastor, DDS,MSC,PhD | Universitat Internacional de Catalunya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat Internacional de Catalunya | Barcelona | Sant Cugat Del Vallès | 08195 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41691512 | Derived | de Tapia B, Babiano A, Oreglia MV, Valles C, Nart J. Impact of Oral Hygiene Instructions in the Resolution of Peri-Implant Mucositis. A Randomized Controlled Trial. Clin Oral Implants Res. 2026 Apr;37(4):509-522. doi: 10.1111/clr.70098. Epub 2026 Feb 15. |
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The results obtained are expected to be published in both national and international journals. In addition, the results will be disseminated national and international scientific events.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2024 | Jul 29, 2024 | Prot_SAP_000.pdf |
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| 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 |
|
| 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. |