PeriodontitisNCT04527913
Interdental Plaque Reduction and Periodontitis
A study testing Interdental Oral Hygiene Instruction (Int-OHI), One session of professional supragingival scaling and polishing and Oral Hygiene Instruction (OHI) in people with Periodontitis, run by University of Pisa at 1 site in Italy.
Trial summary
To determine the efficacy of four different oral hygiene protocols involving adjunctive interdental cleaning devices in periodontal patients in terms of plaque and gingival inflammatory scores. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Interdental Oral Hygiene Instruction (Int-OHI), One session of professional supragingival scaling and polishing and Oral Hygiene Instruction (OHI)
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2011to Aug 2020
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- males or females of age range between 18 and 70 years,
- good health status,
- presence of at least 20 natural teeth
- residual periodontal pockets with PPD≥4mm, in need of specific oral hygiene regimen.
Who cannot join
- pregnancy or breast-feeding,
- indication to antibiotic therapy prior to treatment,
- chronic infections,
- systemic diseases (including cardiovascular, pulmonary, cerebral, and metabolic diseases),
- not willing to give a consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interdental Plaque Reduction After Use of Different Devices in Patients With Periodontitis: a Randomized Clinical Trial
To determine the efficacy of four different oral hygiene protocols involving adjunctive interdental cleaning devices in periodontal patients in terms of plaque and gingival inflammatory scores.
Read the detailed description
Patients included in the study will undergo a thorough clinical examination aiming at collecting all the data desired: periodontal parameters of Probing Pocket Depth (PPD), presence of recession of the gingival margin (Rec) and full mouth plaque score (FMPS) will be recorded on six sites/tooth by a single calibrated examiner using a University of North Carolina (UNC) 15-mm periodontal probe by a calibrated examiner blind to group allocation.
Gingival index (GI) and angulated bleeding score (AngBS) will be recorded at four sites/tooth.
For GI the following scale will be used:
0 normal appearance of gingiva, no bleeding, no inflammation;
- slight change and moderate edema with slight change in texture, no bleeding, mild inflammation;
- redness hypertrophy, or edema and glazing, bleeding on probing, moderate inflammation;
- marked redness, hypertrophy, or edema, ulceration, spontaneous bleeding, severe inflammation.
For AngBS the following scale will be used:
0: no bleeding;
- bleeding upon probe stimulation;
- spontaneous bleeding
Consequently, interdental plaque score (IPS), interdental gingival index (IGI), and interdental angulated bleeding score (IAngBI) will be calculated.
Patients will be followed through a five-week period. The timepoints will be the following: T -7 (oral hygiene instructions), T0 (professional supragingival scaling and polishing), T14, T28.
- Conditions
- Periodontitis
- Being tested
- Interdental Oral Hygiene Instruction (Int-OHI), One session of professional supragingival scaling and polishing, Oral Hygiene Instruction (OHI)
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdental Oral Hygiene Instruction (Int-OHI)Behavioural
Int-OHI will be given focusing on the interdental device of the allocated group for each patient and will be given only once at timepoint T-7. No further formal Int-OH instructions will be given, unless specifically asked by the patient.
Int-OHI will be delivered by trained dental hygienist/periodontist.
One session of professional supragingival scaling and polishingProcedure or surgery
A session of professional supragingival scaling and polishing: instrumentation will be performed by a trained dental hygienist/periodontist with great care in performing exclusively coronal maneuver. No instrumentation or exploring of the gingival crevice/ sulcus will be performed.
Oral Hygiene Instruction (OHI)Procedure or surgery
OHI will be given focusing on manual toothbrushing and will be given only once at timepoint T-7. No further formal OH instructions will be given, unless specifically asked by the patient.
OHI will be delivered by trained dental hygienist/periodontist.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | 15 patients receiving oral hygiene instructions as determined by their group allocation (use of manual toothbrush alone) Receives: Procedure: One session of professional supragingival scaling and polishing; Procedure: Oral Hygiene Instruction (OHI) |
| Test group 1 | Experimental | 15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus dental floss) Receives: Behavioral: Interdental Oral Hygiene Instruction (Int-OHI); Procedure: One session of professional supragingival scaling and polishing; Procedure: Oral Hygiene Instruction (OHI) |
| Test group 2 | Experimental | 15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus interdental brushes) Receives: Behavioral: Interdental Oral Hygiene Instruction (Int-OHI); Procedure: One session of professional supragingival scaling and polishing; Procedure: Oral Hygiene Instruction (OHI) |
| Test group 3 | Experimental | 15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus rubber interdental picks) Receives: Behavioral: Interdental Oral Hygiene Instruction (Int-OHI); Procedure: One session of professional supragingival scaling and polishing; Procedure: Oral Hygiene Instruction (OHI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
FMPS Full-mouth plaque score (FMPS)
Changes in FMPS, measured orally through clinical examination. Unit of measure: N
Measured: Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks
Secondary outcomes (5)
Pocket probing depth (PPD)
Changes in PPD, measured orally through clinical examination. Unit of measure: mm
Measured: Measured at Baseline and at 5 weeks
Recession of the gingival margin (REC)
Changes in REC, measured orally through clinical examination. Unit of measure: mm
Measured: Measured at Baseline and at 5 weeks
Clinical attachment level (CAL)
Changes in CAL, measured orally through clinical examination. Unit of measure: mm
Measured: Measured at Baseline and at 5 weeks
Gingival Index (GI)
Changes in GI, measured orally through clinical examination. Unit of measure: scale from 0 (normal) to 3 (Marked redness, hypertrophy, or edema, ulceration)
Measured: Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks
Angulated bleeding score (AngBS)
Changes in AngBS, measured orally through clinical examination. Unit of measure: scale from 0 (no bleeding), 1 (bleeding upon probe stimulation) to 2 (spontaneous bleeding).
Measured: Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study startSep 2011
- Primary completionJun 2019
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre randomized, parallel design, clinical trial with a five-week follow-up
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filippo Graziani, DDS MClinDent PhD, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527913
- Sponsor's protocol ID
- Periobrush
- Status last verified
- Nov 2022
- First submitted
- 12 Aug 2020
- Last updated
- 7 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdental Plaque Reduction After Use of Different Devices in Patients With Periodontitis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04527913
- Acronym / sponsor ID
- Periobrush
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- Sep 2011 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the efficacy of four different oral hygiene protocols involving adjunctive interdental cleaning devices in periodontal patients in terms of plaque and gingival inflammatory scores.
Detailed description
Patients included in the study will undergo a thorough clinical examination aiming at collecting all the data desired: periodontal parameters of Probing Pocket Depth (PPD), presence of recession of the gingival margin (Rec) and full mouth plaque score (FMPS) will be recorded on six sites/tooth by a single calibrated examiner using a University of North Carolina (UNC) 15-mm periodontal probe by a calibrated examiner blind to group allocation.
Gingival index (GI) and angulated bleeding score (AngBS) will be recorded at four sites/tooth.
For GI the following scale will be used:
0 normal appearance of gingiva, no bleeding, no inflammation;
- slight change and moderate edema with slight change in texture, no bleeding, mild inflammation;
- redness hypertrophy, or edema and glazing, bleeding on probing, moderate inflammation;
- marked redness, hypertrophy, or edema, ulceration, spontaneous bleeding, severe inflammation.
For AngBS the following scale will be used:
0: no bleeding;
- bleeding upon probe stimulation;
- spontaneous bleeding
Consequently, interdental plaque score (IPS), interdental gingival index (IGI), and interdental angulated bleeding score (IAngBI) will be calculated.
Patients will be followed through a five-week period. The timepoints will be the following: T -7 (oral hygiene instructions), T0 (professional supragingival scaling and polishing), T14, T28.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Single-centre randomized, parallel design, clinical trial with a five-week follow-up
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Procedure: One session of professional supragingival scaling and polishing, Procedure: Oral Hygiene Instruction (OHI)15 patients receiving oral hygiene instructions as determined by their group allocation (use of manual toothbrush alone) |
| Test group 1 | Experimental | Behavioral: Interdental Oral Hygiene Instruction (Int-OHI), Procedure: One session of professional supragingival scaling and polishing, Procedure: Oral Hygiene Instruction (OHI)15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus dental floss) |
| Test group 2 | Experimental | Behavioral: Interdental Oral Hygiene Instruction (Int-OHI), Procedure: One session of professional supragingival scaling and polishing, Procedure: Oral Hygiene Instruction (OHI)15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus interdental brushes) |
| Test group 3 | Experimental | Behavioral: Interdental Oral Hygiene Instruction (Int-OHI), Procedure: One session of professional supragingival scaling and polishing, Procedure: Oral Hygiene Instruction (OHI)15 patients receiving oral hygiene instructions as determined by their group allocation (manual toothbrush plus rubber interdental picks) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- males or females of age range between 18 and 70 years,
- good health status,
- presence of at least 20 natural teeth
- residual periodontal pockets with PPD≥4mm, in need of specific oral hygiene regimen.
Key exclusion criteria (5 listed)
- pregnancy or breast-feeding,
- indication to antibiotic therapy prior to treatment,
- chronic infections,
- systemic diseases (including cardiovascular, pulmonary, cerebral, and metabolic diseases),
- not willing to give a consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interdental Oral Hygiene Instruction (Int-OHI)Int-OHI will be given focusing on the interdental device of the allocated group for each patient and will be given only once at timepoint T-7. No further formal Int-OH instructions will be given, unless specifically asked by the patient. Int-OHI will be delivered by trained dental hygienist/periodontist. | Behavioural | Test group 1, Test group 2, Test group 3 |
| One session of professional supragingival scaling and polishingA session of professional supragingival scaling and polishing: instrumentation will be performed by a trained dental hygienist/periodontist with great care in performing exclusively coronal maneuver. No instrumentation or exploring of the gingival crevice/ sulcus will be performed. | Procedure or surgery | Control group, Test group 1, Test group 2, Test group 3 |
| Oral Hygiene Instruction (OHI)OHI will be given focusing on manual toothbrushing and will be given only once at timepoint T-7. No further formal OH instructions will be given, unless specifically asked by the patient. OHI will be delivered by trained dental hygienist/periodontist. | Procedure or surgery | Control group, Test group 1, Test group 2, Test group 3 |
Primary outcome
FMPS Full-mouth plaque score (FMPS)
Time frame: Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks
Changes in FMPS, measured orally through clinical examination. Unit of measure: N
5 secondary outcomes
Pocket probing depth (PPD)
Time frame: Measured at Baseline and at 5 weeks
Recession of the gingival margin (REC)
Time frame: Measured at Baseline and at 5 weeks
Clinical attachment level (CAL)
Time frame: Measured at Baseline and at 5 weeks
Gingival Index (GI)
Time frame: Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks
Angulated bleeding score (AngBS)
Time frame: Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interdental Oral Hygiene Instruction (Int-OHI), One session of professional supragingival scaling and polishing and Oral Hygiene Instruction (OHI) in people with Periodontitis, run by University of Pisa at 1 site in Italy.
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 4 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 7 Nov 2022. 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 Italy. 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?
FMPS Full-mouth plaque score (FMPS) (time frame: Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2022.