Periodontal DiseasesNCT05439785
Plaque Control Efficacy Between Interdental Brushes Versus Dental Floss
A study testing Dental floss/Interdental brush in people with Periodontal Diseases and Dental Plaque, run by Fatima Jinnah Dental College at 1 site in Pakistan.
Trial summary
The purpose of this study is to compare between plaque control efficacy of interdental brushes versus interdental floss , for the prevention of periodontal disease (gingivitis) and to determine the most convenient routine interdental plaque control method amongst the two Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Dental Plaque
- What is being tested?
- Dental floss/Interdental brush
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2022to 30 May 2022
- 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
- All patients above 18 years of age with gingivitis
- patients of both gender
Who cannot join
- patients who refuse participate in the study
- patients with systemic medical problems
- patients using medications that may affect gingival tissue (overgrowth/bleeding)
- patients habitual of betel nut/tobacco smoking/substance abuse
- patients with fluorosis or any other enamel and dentinal deformity
- pregnant women
- patients undergoing orthodontic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Plaque Control Efficacy Between Interdental Brushes Versus Dental Floss in Patients With Periodontal Disease
The purpose of this study is to compare between plaque control efficacy of interdental brushes versus interdental floss , for the prevention of periodontal disease (gingivitis) and to determine the most convenient routine interdental plaque control method amongst the two
- Conditions
- Periodontal Diseases, Dental Plaque
- Being tested
- Dental floss/Interdental brush
- Medical subject headings
- Periodontal Diseases, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental floss/Interdental brushDevice
Initially plaque disclosing tablets were used to disclose plaque and plaque and bleeding scores will be recoded. After mechanical plaque debrided, instructions regarding the allocated interdental device given to the patient along with motivation to continue practicing good oral hygiene. After six weeks patients were recalled for reevaluation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Dental floss Receives: Device: Dental floss/Interdental brush |
| Group 2 | Experimental | Interdental brush Receives: Device: Dental floss/Interdental brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in plaque score records according to Silness and Loe and O'Leary et al plaque score/index at week 6
Silness and Loe Plaque Index and O'Leary et al plaque index are used as tools to measure plaque score by disclosing plaque, using a chewable plaque disclosing tablet. Possible score range from 0 (absence of microbial plaque) to 3 (large amount of plaque in sulcus or pocket along the free gingiva margin). Change = ( week 6 score - baseline score)
Measured: baseline and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Apr 2022
- Primary completion20 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatima Jinnah Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madiha Sultan, Fatima Jinnah Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439785
- Sponsor's protocol ID
- FatimaJDC420
- Status last verified
- Jun 2022
- First submitted
- 6 Jun 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Plaque Control Efficacy Between Interdental Brushes Versus Dental Floss in Patients With Periodontal Disease
- ClinicalTrials.gov ID
- NCT05439785
- Acronym / sponsor ID
- FatimaJDC420
- Conditions
- Periodontal Diseases, Dental Plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Fatima Jinnah Dental CollegeUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 30 Jun 2022 (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 this study is to compare between plaque control efficacy of interdental brushes versus interdental floss , for the prevention of periodontal disease (gingivitis) and to determine the most convenient routine interdental plaque control method amongst the two
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Dental floss/Interdental brushDental floss |
| Group 2 | Experimental | Device: Dental floss/Interdental brushInterdental brush |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients above 18 years of age with gingivitis
- patients of both gender
Key exclusion criteria (7 listed)
- patients who refuse participate in the study
- patients with systemic medical problems
- patients using medications that may affect gingival tissue (overgrowth/bleeding)
- patients habitual of betel nut/tobacco smoking/substance abuse
- patients with fluorosis or any other enamel and dentinal deformity
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 |
|---|---|---|
| Dental floss/Interdental brushInitially plaque disclosing tablets were used to disclose plaque and plaque and bleeding scores will be recoded. After mechanical plaque debrided, instructions regarding the allocated interdental device given to the patient along with motivation to continue practicing good oral hygiene. After six weeks patients were recalled for reevaluation | Device | Group 1, Group 2 |
Primary outcome
Change from baseline in plaque score records according to Silness and Loe and O'Leary et al plaque score/index at week 6
Time frame: baseline and week 6
Silness and Loe Plaque Index and O'Leary et al plaque index are used as tools to measure plaque score by disclosing plaque, using a chewable plaque disclosing tablet. Possible score range from 0 (absence of microbial plaque) to 3 (large amount of plaque in sulcus or pocket along the free gingiva margin). Change = ( week 6 score - baseline score)
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 30 Jun 2022.
- Individual participant dataSharing planned: No
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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 Dental floss/Interdental brush in people with Periodontal Diseases and Dental Plaque, run by Fatima Jinnah Dental College at 1 site in Pakistan.
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 2 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 30 Jun 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 Pakistan. 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 in plaque score records according to Silness and Loe and O'Leary et al plaque score/index at week 6 (time frame: baseline and week 6). 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 30 Jun 2022.