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Peri-implant MucositisNCT06535958

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

A study testing OHI and OHI+PMPR in people with Peri-implant Mucositis, run by Universitat Internacional de Catalunya at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peri-implant Mucositis
What is being tested?
OHI and OHI+PMPR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteSpain
Study dates
16 Sep 2024to 9 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universitat Internacional de Catalunya

    Barcelona, Sant Cugat Del Vallès, 08195

Other trials in Spain

About this study

Official title: Impact of Oral Hygiene Instructions in the Resolution of Peri-implant Mucositis. A Randomized Clinical Trial

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.
Being tested
OHI, OHI+PMPR

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OHIBehavioural

    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

  • OHI+PMPRProcedure or surgery

    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

Study groups in NCT06535958
Study groupRoleWhat they receive
Test group (OHI)ExperimentalNot described
Receives: Behavioral: OHI
Control Group (OHI+PMPR)ExperimentalNot described
Receives: Behavioral: OHI; Procedure: OHI+PMPR

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At baseline, 1 and 3 months after treatment

Secondary outcomes (6)

  1. 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.

    Measured: At baseline, 1 and 3 months after treatment

  2. 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.

    Measured: At baseline, 1 and 3 months after treatment

  3. 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.

    Measured: At baseline, 1 and 3 months after treatment

  4. 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

    Measured: At baseline, 1 and 3 months after treatment

  5. 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.

    Measured: At baseline, 1 and 3 months after treatment

  6. Microbiological test

    Sterile paper points. Detect the absence or presence of certain types of bacteria

    Measured: At baseline, 1 and 3 months after treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2024
  2. Study start16 Sep 2024
  3. Primary completion9 Jan 2025
  4. Study completion9 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06535958
Sponsor's protocol ID
PER-ECL-2023-07
Status last verified
Apr 2025
First submitted
30 Jul 2024
Last updated
10 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 41691512

Questions about this trial

What is this clinical trial studying?

A study testing OHI and OHI+PMPR in people with Peri-implant Mucositis, run by Universitat Internacional de Catalunya at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified bleeding index (time frame: At baseline, 1 and 3 months after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06535958, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.

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