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PeriodontitisNCT05565404

Effect of mHealth on Interdental Brushing in Type 2 Embrasures"

A study testing mobile health and Scaling and root planing+Interdental aid in people with Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Plaque biofilm is the etiological factor for the development of gingival and periodontal diseases. There are certain areas in mouth where plaque removal is difficult, which includes palatal, lingual and interproximal areas. Read more about this study

Who is it for?
Ages 30 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Periodontitis
What is being tested?
mobile health and Scaling and root planing+Interdental aid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteIndia
Study dates
1 Nov 2022to 30 Jun 2024
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 30 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patients with type 2 embrasures, with atleast 4 interdental spaces eligible for use of interdental brush.
  • 2 or 3 periodontitis with probing pocket depth ≤5mm.
  • Age - 30-55 years.
  • Patients who own mobile phones.
  • Patients who can read and write.
  • No history of performing interdental oral hygiene on regular basis.
  • Patients willing to comply with the given instructions regarding the use of interdental brush.

Who cannot join

  • Smokers and orthodontic patients.
  • Patient with systemic disease that can influence the outcome of therapy.
  • Physically and mentally impaired patients.
  • Patient on drugs associated with gingival overgrowth.
  • Pregnant females.
  • Patients on oral contraceptives or hormone replacement therapy.
  • Overhanging restorations.
  • Patients using any other cleaning aids like mouthwash.

Trial locations and contacts

1 site in 1 country.

Nishi Tanwar, MDS contact

8368126310

nsh_tanwar@yahoo.co.in

India1 site, 1 recruiting
  • Post Graduate Institute of Dental Sciences

    Rohtak, Haryana, 124001

    NISHI TANWAR, MDS, 8368126310, nsh_tanwar@yahoo.co.in

    Recruiting

Other trials in India

About this study

Official title: Effect of Mobile Health(mHealth) on Interdental Brushing in Type 2 Embrasures": A Randomized Controlled Clinical Trial.

Plaque biofilm is the etiological factor for the development of gingival and periodontal diseases. There are certain areas in mouth where plaque removal is difficult, which includes palatal, lingual and interproximal areas. Among these, interproximal areas are most difficult to clean due to inability of toothbrush to reach that area properly. So, interdental aids are required to remove plaque from the proximal areas efficiently. Consequently, plaque accumulation most often starts in interdental areas, where resultant periodontal lesions are observed most commonly. It is the ethical responsibility of the dental professional to educate patients about the progression of destructive periodontal disease, so that patients understand the need for plaque removal and control. It is not easy for patients to develop any new habits of using different cleaning aids. Many studies have proven mobile health to be effective in improving patient's compliance for better oral hygiene maintenance. So, proper means of education such as mobile health could lead to behavior change and adoption of new habit of using interdental aid on regular basis. Use of mobile technology to track and improve health outcomes is known as mobile health. No studies till date have evaluated mobile health in improving interdental brushing. It is possible that we can reinforce patient on the use of interdental brush with the help of text messages. Therefore, the present randomized controlled clinical trial is designed to evaluate the compliance of interdental brushing with the use of text messages.

Read the detailed description

Dental plaque is considered to be a biofilm of dynamic and complex microbial community. Microbial composition of plaque varies in every individual and at every site within the same mouth. Plaque accumulation leads to development of gingival and periodontal diseases. It usually takes 7 to 21 days to develop gingivitis in the absence of plaque removal. Plaque control is necessary for maintaining the oral tissues, especially the gingiva, in a healthy state. Primary means of plaque control is through mechanical action, with the toothbrush being the most common means of plaque removal. While it removes plaque efficiently from the buccal, lingual and occlusal surfaces, it fails to do the same at interproximal sites. Consequently, plaque accumulation most often starts in interdental areas, where resultant periodontal lesions are observed most commonly. This makes interdental cleaning very necessary, in addition to toothbrushing, for prevention of gingival and periodontal diseases.

In type 2 embrasure patients, interdental brush is prescribed. It consists of soft nylon filaments twisted into a fine stainless steel wire. These interdental brushes are available in different sizes and shapes. The most common types are cylindrical or conical. They are available in different diameters according to interdental space, ranging from 1.9 to 14mm. Selected brush should be slightly larger than the embrasure space. Introduction of brush in interdental space should be done obliquely, from the apical direction and used with back-and-forth motion. In type 2 embrasure patients, interdental brush is prescribed. It consists of soft nylon filaments twisted into a fine stainless steel wire. These interdental brushes are available in different sizes and shapes. The most common types are cylindrical or conical. They are available in different diameters according to interdental space, ranging from 1.9 to 14mm. Selected brush should be slightly larger than the embrasure space. Introduction of brush in interdental space should be done obliquely, from the apical direction and used with back-and-forth motion.

Use of mobile phone has increased globally; over half of world's 6.5 billion people use mobile phone services. wireless subscription in India stands at 952.34 million (in urban 553.45million whereas in rural 398.89) at the end of January 2015. Use of mobile technology to improve health outcomes is known as mobile health (mHealth). Text messages have become very common now and can be used to educate and motivate patients. Studies in medicine and dentistry have shown that text messaging is a very efficient tool for behavioral change and disease prevention. Use of mobile phone has increased globally; over half of world's 6.5 billion people use mobile phone services. wireless subscription in India stands at 952.34 million (in urban 553.45million whereas in rural 398.89) at the end of January 2015. Use of mobile technology to improve health outcomes is known as mobile health (mHealth). Text messages have become very common now and can be used to educate and motivate patients. Studies in medicine and dentistry have shown that text messaging is a very efficient tool for behavioral change and disease prevention.

The present prospective, randomized controlled clinical trial will be conducted in the department of Periodontics and Oral Implantology, Post Graduate Institute of Dental Sciences, Rohtak, Haryana. Duration of study will be 12 to 14 months and Patients will be recruited from the outpatient department of Periodontology. It will be divided into two groups, Test group will include scaling and root planing, interdental brushing demonstration and text messages in type 2 embrasure patients and Control group will include scaling and root planing, interdental brushing demonstration in type 2 embrasure patients.

All the participants will undergo phase 1 therapy with a combination of hand scalers and curettes and ultrasonic scaler. Standardized oral hygiene instructions will be imparted and will be reinforced at each appointment.

Most snugly fitted interdental brush will be selected and patient will be asked to pass interdental brush from buccal to lingual aspect of interdental area and then back out again while depressing the interdental papilla to allow bristles to reach sub-gingivally. Regular text messages twice a week, will be sent to the patients in the test group which will include reminder messages for interdental brushing. Patient will be asked to respond to messages.

Text message content for Reminder for using INTERDENTAL BRUSH

Primary outcome will include Plaque Index (Turesky modified Quigley \& Hein) and Papillary Bleeding Index and secondary outcome will include Clinical attachment level (CAL), Gingival Index (GI), Pocket probing depth (PPD), Bleeding on probing (BOP), Interdental papilla height.

Papillary bleeding index will be measured at mesial and distal papilla of each tooth with Periodontal probe.

Plaque index will be measured on buccal and lingual surface with Periodontal probe.

Gingival index will be used to assess severity of gingival inflammation with the help of periodontal probe at 4 sites (Buccal, lingual, mesial and distal).

Clinical attachment level will be measured as the distance between the cemento-enamel junction and the base of pocket. Measurements will be made at 6 sites of each tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual) using Periodontal probe.

Probing pocket depth will be measured as the distance from gingival margin to the base of pocket. Measurements will be noted at 6 sites of a tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual).

Interdental papilla height will be measured as the distance from the tip of papilla to an imaginary line connecting most apical point of gingival zenith of adjacent teeth with the help of calibrated probe.

Conditions
Periodontitis
Being tested
mobile health, Scaling and root planing+Interdental aid
Keywords
interdental brush, type 2 embrasures, text messages
Medical subject headings
Periodontitis

What participants receive

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

  • mobile healthBehavioural

    Scaling and root planing, interdental brushing demonstration and regular text messages in type 2 embrasure patients.

  • Scaling and root planing+Interdental aidProcedure or surgery

    Scaling and root planing, interdental brushing demonstration in type 2 embrasure patients.

Study groups in NCT05565404
Study groupRoleWhat they receive
Test groupExperimentalScaling and root planing, interdental brushing demonstration and regular text messages in type 2 embrasure patients.
Receives: Behavioral: mobile health
Control groupActive comparatorScaling and root planing, interdental brushing demonstration in type 2 embrasure patients.
Receives: Procedure: Scaling and root planing+Interdental aid

What is being measured

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

  1. Plaque Index

    Quigley \& Hein modification will be used which will measure the plaque level on buccal, labial and lingual surface of teeth with the help of disclosing agent.0 = no plaque

    1. = separate flecks of plaque at the cervical margin of the tooth
    2. = a thin continuous band of plaque (up to 1 mm) at the cervical margin
    3. = a band of plaque wider than 1 mm but covering less than 1/3 of crown
    4. = plaque covering at least 1 /3 but less than 2/3 of the crown
    5. = plaque covering 2/3 or more of crown

    Measured: 6 months

  2. Papillary Bleeding Index

    • Papillary bleeding index by Saxer et al will be used to assess gingival bleeding. A blunt periodontal probe was carefully inserted into the gingival sulcus at the base of the papilla on the mesial aspect, then moved coronally to the papilla tip. This was repeated on the distal aspect of the same papilla. The intensity of any bleeding thus provoked was recorded on a 0-4scale. Score 0 No bleeding Score 1- A single discreet bleeding point appears Score 2 - Several isolated bleeding points or a single fine line of blood appears

    Score 3 - The interdental triangle fills with blood shortly after probing Score 4- Profuse bleeding occurs after probing blood flows immediately into the marginal sulcus

    Measured: 6 months

Timeline

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

  1. First posted4 Oct 2022
  2. Study start1 Nov 2022
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Jun 2024 (estimated)

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
Investigator
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05565404
Sponsor's protocol ID
Jyoti yadav perio 22/26
Status last verified
May 2023
First submitted
29 Sep 2022
Last updated
12 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yadav J, Tanwar N, Sharma RK, Sangwan A. Mobile Health to Improve Efficacy of Interdental Brushing Among Periodontitis Patients: A Randomized Clinical Trial. J Periodontal Res. 2025 Jun;60(6):559-569. doi: 10.1111/jre.13362. Epub 2024 Nov 25.

    PubMed 39584464

Questions about this trial

What is this clinical trial studying?

A study testing mobile health and Scaling and root planing+Interdental aid in people with Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 May 2023. 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 India. 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?

Results are not available in the source record.

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

Contact Nishi Tanwar, MDS (8368126310, nsh_tanwar@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plaque Index (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT05565404, 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 12 May 2023.

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