GingivitisNCT03848351
Oral Hygiene and Systemic Inflammation (Perio-Hygiene 1.0)
A study testing Oral Hygiene Instruction (OHI) and Professional supragingival scaling and polishing in people with Gingivitis, run by University of Pisa at 1 site in Italy.
Trial summary
The purpose of the study is to evaluate the impact of oral hygiene changes (drastic plaque and gingival inflammation reduction) on markers of systemic inflammation and indicators of oral health related quality of life and other aspects related to overall well-being. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Oral Hygiene Instruction (OHI) and Professional supragingival scaling and polishing
- 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
- 140 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2019to 4 May 2021
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male or female, 18 to 79 of age, of any race/ethnicity;
- presence of at least 20 teeth;
- ≤ 2 untreated dental caries;
- presence of relevant plaque accumulation as shown by Full Mouth Plaque Scores (FMBS) >50%.
- presence of relevant periodontal/gingival inflammation as shown by FMBS > 35%
Who cannot join
- • pregnancy and breast feeding;
- patients undergoing pharmacological treatment capable of reducing CRP such as statins or chronic anti-inflammatory treatment,
- current or past (≤ 30 days) systemic or local antibiotic therapy;
- heavy smokers (over 20 cigarettes per day or pipe or cigar);
- patients undergoing orthodontic treatment;
- patients not capable to comply with given instruction or administrative issues related to the study
- dental or periodontal conditions (e.g., deep caries, periodontal abscess) requiring urgent treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Correct and Efficient Oral Hygiene Maneuvers on Markers of Systemic Inflammation and Overall Well-being.
The purpose of the study is to evaluate the impact of oral hygiene changes (drastic plaque and gingival inflammation reduction) on markers of systemic inflammation and indicators of oral health related quality of life and other aspects related to overall well-being.
The primary objective is to assess a possible reduction of systemic inflammation as measured through blood bio-markers one month after drastic changes of plaque accumulation. As primary outcome measure, the level of high-sensitive C-reactive protein (hs-CRP) will be assessed.
Read the detailed description
This study is a single-center, 2 arms, randomized parallel group double-blind clinical trial with one month follow-up, involving patients with no conditions capable of alteration of the systemic inflammatory levels as measured by C-reactive protein (CRP).
Screening will be actuated through a two-step procedure: a careful dental and medical examination will be collected. Subjects with negative history for the conditions tested will undergo blood testing to further confirm the anamnestic findings. Center investigators will document in a screening log reasons for ineligibility or exclusion of subjects. Thus, subjects fulfilling the inclusion criteria will be invited to participate. Clinical center will enroll probands, assigning a unique study subject number and allocating an opaque randomization envelope.
Informed consent will be obtained by the center investigator who will describe the objectives of the study, the alternatives and risks associated with study participation as well as the possibility to withdraw at any time without compromise for the treatment. Consent procedures and documentation of consent will be performed at the screening visit in the national language of the patient and in accordance with local best practice and regulations.
Patients included in the study will undergo a thorough clinical examination aiming at collecting all the data desired (oral and systemic parameters, blood sampling and questionnaires fulfilment). After examinations, the opaque envelope with associated the code of the patient will be opened identifying whether the patient enters Test or Control group.
Patients will also receive 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.
Subjects in the Test group will receive a thorough session of oral hygiene instruction (OHI) and a full oral hygiene kit.
OHI will be given focusing on electric toothbrushing as first instance and subsequently focusing on interdental cleaning. OHI will be delivered by trained dental hygienist/periodontist.
OHI will be given directly on the patient's mouth. In the first phase the clinician will explain and show the technique to the patient. The patient will be then invited to perform the technique. Each phase will be assisted and monitored by the clinician. Overall, this sequence may be repeated as many times as the clinician would deem appropriate.
Subjects in the control group will be invited to attend another examination in 4 weeks (T28)
Every week, included subjects in the Test group will attend session of OHI re-enforcement and plaque control in order to achieve optimal plaque control. Ideally a value below 20% should be aimed as shown already to be consistent with findings from our research group.
Patients of both groups will undergo clinical examinations, questionnaires and blood withdrawal. The clinical examinations will be performed by examiners blind to group allocation. Participants will be asked by the study coordinators not to disclose to the examiners whether they belong to Test or Control group.
Any periodontal treatment, or professional scaling will be forbidden after the inclusion (T0). For patient allocated in the Test group any pharmacological treatment prescription, or any devices administration different from this study protocol guidelines will be prohibited. In particular, if the patients, in both test or control group, will have to undergo treatment capable of influencing CRP (statins) this will be highlighted and the patient excluded from the study. If withdrawal for prohibited intervention occurs, a new patient enrolment will be activated.
Individuals will be free to quit the study at any time. Patients who will fail to comply with T28 VISIT will be excluded from the study.
- Conditions
- Gingivitis
- Being tested
- Oral Hygiene Instruction (OHI), Professional supragingival scaling and polishing
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Hygiene Instruction (OHI)Behavioural
OHI will be given focusing on electric toothbrushing as first instance and subsequently focusing on interdental cleaning. OHI will be delivered by trained dental hygienist/periodontist. In the first phase the clinician will explain and show the technique to the patient. The patient will be then invited to perform the technique. Each phase will be assisted and monitored by the clinician. Overall, this sequence may be repeated as many times as the clinician would deem appropriate.
Professional supragingival scaling and polishingProcedure or surgery
Patients will receive a session of professional supragingival scaling and polishing, that consists of removal of dental plaque and dental calculus from the surface of a tooth, with great care in performing exclusively coronal maneuver. No instrumentation or exploring of the gingival crevice/ sulcus will be performed. Instrumentation will be performed by a trained dental hygienist/periodontist.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | 70 patients not receiving oral hygiene instructions or devices and continuing with their routine oral hygiene habits |
| Test Group | Active comparator | 70 patients receiving intense oral hygiene instructions assisted by specific software or devices as well as oral hygiene (OH) tools (electric toothbrush, interdental floss, toothpaste) Thus, interventions will consist of.
* Oral Hygiene Instruction (OHI)
* Professional supragingival scaling and polishing Receives: Behavioral: Oral Hygiene Instruction (OHI); Procedure: Professional supragingival scaling and polishing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of High sensitivity C-Reactive Protein (hsCRP) at 1 month
analyzed though blood sampling. Unit of measure: mg/L
Measured: Difference of values of the markers collected at Baseline and 1 month after treatment
Secondary outcomes (12)
Change from baseline of Interleukin 6 at 1 month
analyzed though blood sampling. Unit of measure: nmol/L (ng/mL)
Measured: Difference of values of the markers collected at Baseline and 1 month after treatment
Vitamin D
analyzed though blood sampling. Unit of measure: nmol/L
Measured: Collected at Baseline
Full-mouth plaque score (FMPS)
Changes in Full-mouth plaque score, measuring the amount of dental plaque on the teeth orally through clinical examination. Unit of measure %. The scale ranges from 0% (minimum value, i.e. plaque absent) to 100% (maximum value: all areas are occupied by plaque). 0% would the ideal value. No sub-scales are included.
Measured: Measured at Baseline and 1 month after treatment
Full-mouth bleeding score (FMBS)
Changes of Full-mouth bleeding score, measuring the number of gingival areas that bleed after gingival probe passage. It is measured orally through clinical examination. Unit of measure %. The scale ranges from 0% (minimum value, i.e. gingival inflammation is absent) to 100% (maximum value: all gingival areas are inflamed). 0% would the ideal value. No sub-scales are included.
Measured: Measured at Baseline and 1 month after treatment
Pocket probing depth (PPD)
Changes in PPD, measured orally through clinical examination. Unit of measure: mm (PPD=distance between the gingival margin and the deepest part of the gingival pocket)
Measured: Measured at Baseline and 1 month after treatment
Recession of the gingival margin (REC)
Changes in REC, measured orally through clinical examination. Unit of measure: mm (REC=distance in mm from the cement-enamel junction (CEJ) to the gingival margin )
Measured: Measured at Baseline and 1 month after treatment
Clinical attachment level (CAL)
Changes in CAL, measured orally through clinical examination. Unit of measure: mm (CAL)
: calculated as the sum of PPD and REC)
Measured: Measured at Baseline and 1 month after treatment
Changes of sum of Oral Health Index Profile-14
Changes in Oral Health Index Profile-14 measured through administration of specific questionnaire. Each of the 14 questions can be answered with a Likert scale reporting from "never" to "always" translated to 1 and 5 respectively. Thus, a maximum value (sum) of 70.
Measured: Measured at Baseline and 1 month after trea
Changes of sum of Pittsburgh sleep quality index (PSQI)
Changes in PSQI measured through administration of specific questionnaires. It is a validated questionnaire of 19 self-questions aiming at assessing statements grouped in 7 component scores: sleep quality, latency, duration, habitual sleep efficiency, disturbances, uses of sleep medications and day time dysfunction. Component scores range between 0 and 3, with 0= "no difficulty" and 3= "severe difficulty". Total score ranges between 0-21. If the patient has a bed partner it is possible to add 5 questions to be filled by the partner, about the sleep quality of the patient.
Measured: Measured at Baseline and 1 month after trea
Changes of sum of Memory Assessment Clinics - Questionnaire (MAC-Q)
Changes in MAC-Q measured through administration of specific questionnaire. It is a validated questionnaire of 6 self-questions aiming at assessing the quality of the memory in comparison to the period of high school or college. Each question is rated with a 5-point scale, with 1= "much better now" and 5= "much poorer now". The final question is a global evaluation of the memory, so it has more weight in the scoring system and is evaluated in a 10-point scale. Total score range is comprised between 7 and 35.
Measured: Measured at Baseline and 1 month after treatment
Changes of sum of Oxford Happiness Questionnaire (OHQ)
Changes in 0HQ measured through administration of specific questionnaire. It is a validated questionnaire that includes items presented as a single statement which can be endorsed on a uniform 6-point Likert scale.
Measured: Measured at Baseline and 1 month after treatment
Food Frequency Questionnaire (FFQ)
FFQ measured through administration of specific questionnaire
Measured: Measured at Baseline and 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start1 Apr 2019
- Primary completion4 May 2021
- Study completion4 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre randomized, parallel design, clinical trial with a 1-month follow-up
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 140 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
- NCT03848351
- Sponsor's protocol ID
- 984/2019
- Status last verified
- Nov 2022
- First submitted
- 15 Feb 2019
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Peric M, Marhl U, Gennai S, Marruganti C, Graziani F. Treatment of gingivitis is associated with reduction of systemic inflammation and improvement of oral health-related quality of life: A randomized clinical trial. J Clin Periodontol. 2022 Sep;49(9):899-910. doi: 10.1111/jcpe.13690. Epub 2022 Jul 17.
PubMed 35762095
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
- The Impact of Correct and Efficient Oral Hygiene Maneuvers on Markers of Systemic Inflammation and Overall Well-being.
- ClinicalTrials.gov ID
- NCT03848351
- Acronym / sponsor ID
- 984/2019
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 20 Feb 2019 (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.
The purpose of the study is to evaluate the impact of oral hygiene changes (drastic plaque and gingival inflammation reduction) on markers of systemic inflammation and indicators of oral health related quality of life and other aspects related to overall well-being.
The primary objective is to assess a possible reduction of systemic inflammation as measured through blood bio-markers one month after drastic changes of plaque accumulation. As primary outcome measure, the level of high-sensitive C-reactive protein (hs-CRP) will be assessed.
Detailed description
This study is a single-center, 2 arms, randomized parallel group double-blind clinical trial with one month follow-up, involving patients with no conditions capable of alteration of the systemic inflammatory levels as measured by C-reactive protein (CRP).
Screening will be actuated through a two-step procedure: a careful dental and medical examination will be collected. Subjects with negative history for the conditions tested will undergo blood testing to further confirm the anamnestic findings. Center investigators will document in a screening log reasons for ineligibility or exclusion of subjects. Thus, subjects fulfilling the inclusion criteria will be invited to participate. Clinical center will enroll probands, assigning a unique study subject number and allocating an opaque randomization envelope.
Informed consent will be obtained by the center investigator who will describe the objectives of the study, the alternatives and risks associated with study participation as well as the possibility to withdraw at any time without compromise for the treatment. Consent procedures and documentation of consent will be performed at the screening visit in the national language of the patient and in accordance with local best practice and regulations.
Patients included in the study will undergo a thorough clinical examination aiming at collecting all the data desired (oral and systemic parameters, blood sampling and questionnaires fulfilment). After examinations, the opaque envelope with associated the code of the patient will be opened identifying whether the patient enters Test or Control group.
Patients will also receive 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.
Subjects in the Test group will receive a thorough session of oral hygiene instruction (OHI) and a full oral hygiene kit.
OHI will be given focusing on electric toothbrushing as first instance and subsequently focusing on interdental cleaning. OHI will be delivered by trained dental hygienist/periodontist.
OHI will be given directly on the patient's mouth. In the first phase the clinician will explain and show the technique to the patient. The patient will be then invited to perform the technique. Each phase will be assisted and monitored by the clinician. Overall, this sequence may be repeated as many times as the clinician would deem appropriate.
Subjects in the control group will be invited to attend another examination in 4 weeks (T28)
Every week, included subjects in the Test group will attend session of OHI re-enforcement and plaque control in order to achieve optimal plaque control. Ideally a value below 20% should be aimed as shown already to be consistent with findings from our research group.
Patients of both groups will undergo clinical examinations, questionnaires and blood withdrawal. The clinical examinations will be performed by examiners blind to group allocation. Participants will be asked by the study coordinators not to disclose to the examiners whether they belong to Test or Control group.
Any periodontal treatment, or professional scaling will be forbidden after the inclusion (T0). For patient allocated in the Test group any pharmacological treatment prescription, or any devices administration different from this study protocol guidelines will be prohibited. In particular, if the patients, in both test or control group, will have to undergo treatment capable of influencing CRP (statins) this will be highlighted and the patient excluded from the study. If withdrawal for prohibited intervention occurs, a new patient enrolment will be activated.
Individuals will be free to quit the study at any time. Patients who will fail to comply with T28 VISIT will be excluded from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-centre randomized, parallel design, clinical trial with a 1-month follow-up
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –70 patients not receiving oral hygiene instructions or devices and continuing with their routine oral hygiene habits |
| Test Group | Active comparator | Behavioral: Oral Hygiene Instruction (OHI), Procedure: Professional supragingival scaling and polishing70 patients receiving intense oral hygiene instructions assisted by specific software or devices as well as oral hygiene (OH) tools (electric toothbrush, interdental floss, toothpaste) Thus, interventions will consist of. * Oral Hygiene Instruction (OHI) * Professional supragingival scaling and polishing |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male or female, 18 to 79 of age, of any race/ethnicity;
- presence of at least 20 teeth;
- ≤ 2 untreated dental caries;
- presence of relevant plaque accumulation as shown by Full Mouth Plaque Scores (FMBS) >50%.
- presence of relevant periodontal/gingival inflammation as shown by FMBS > 35%
Key exclusion criteria (7 listed)
- • pregnancy and breast feeding;
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 |
|---|---|---|
| Oral Hygiene Instruction (OHI)OHI will be given focusing on electric toothbrushing as first instance and subsequently focusing on interdental cleaning. OHI will be delivered by trained dental hygienist/periodontist. In the first phase the clinician will explain and show the technique to the patient. The patient will be then invited to perform the technique. Each phase will be assisted and monitored by the clinician. Overall, this sequence may be repeated as many times as the clinician would deem appropriate. | Behavioural | Test Group |
| Professional supragingival scaling and polishingPatients will receive a session of professional supragingival scaling and polishing, that consists of removal of dental plaque and dental calculus from the surface of a tooth, with great care in performing exclusively coronal maneuver. No instrumentation or exploring of the gingival crevice/ sulcus will be performed. Instrumentation will be performed by a trained dental hygienist/periodontist. | Procedure or surgery | Test Group |
Primary outcome
Change from baseline of High sensitivity C-Reactive Protein (hsCRP) at 1 month
Time frame: Difference of values of the markers collected at Baseline and 1 month after treatment
analyzed though blood sampling. Unit of measure: mg/L
12 secondary outcomes
Change from baseline of Interleukin 6 at 1 month
Time frame: Difference of values of the markers collected at Baseline and 1 month after treatment
Vitamin D
Time frame: Collected at Baseline
Full-mouth plaque score (FMPS)
Time frame: Measured at Baseline and 1 month after treatment
Full-mouth bleeding score (FMBS)
Time frame: Measured at Baseline and 1 month after treatment
Pocket probing depth (PPD)
Time frame: Measured at Baseline and 1 month after treatment
Recession of the gingival margin (REC)
Time frame: Measured at Baseline and 1 month after treatment
Clinical attachment level (CAL)
Time frame: Measured at Baseline and 1 month after treatment
Changes of sum of Oral Health Index Profile-14
Time frame: Measured at Baseline and 1 month after trea
Changes of sum of Pittsburgh sleep quality index (PSQI)
Time frame: Measured at Baseline and 1 month after trea
Changes of sum of Memory Assessment Clinics - Questionnaire (MAC-Q)
Time frame: Measured at Baseline and 1 month after treatment
Changes of sum of Oxford Happiness Questionnaire (OHQ)
Time frame: Measured at Baseline and 1 month after treatment
Food Frequency Questionnaire (FFQ)
Time frame: Measured at Baseline and 1 month after treatment
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.
- Derived from this study: PubMed 35762095Peric M, Marhl U, Gennai S, Marruganti C, Graziani F. Treatment of gingivitis is associated with reduction of systemic inflammation and improvement of oral health-related quality of life: A randomized clinical trial. J Clin Periodontol. 2022 Sep;49(9):899-910. doi: 10.1111/jcpe.13690. Epub 2022 Jul 17.
- 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 Oral Hygiene Instruction (OHI) and Professional supragingival scaling and polishing in people with Gingivitis, 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 5 inclusion and 7 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?
Change from baseline of High sensitivity C-Reactive Protein (hsCRP) at 1 month (time frame: Difference of values of the markers collected at Baseline and 1 month 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 NCT03848351, 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 7 Nov 2022.