NCT05565404

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

1.7 years

First QC Date

September 29, 2022

Last Update Submit

May 11, 2023

Conditions

Keywords

interdental brushtype 2 embrasurestext messages

Outcome Measures

Primary Outcomes (2)

  • 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

    6 months

  • 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

    6 months

Study Arms (2)

Test group

EXPERIMENTAL

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

Behavioral: mobile health

Control group

ACTIVE COMPARATOR

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

Procedure: Scaling and root planing+Interdental aid

Interventions

mobile healthBEHAVIORAL

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

Test group

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

Control group

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with type 2 embrasures, with atleast 4 interdental spaces eligible for use of interdental brush.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Periodontitis

Interventions

TelemedicineTooth Exfoliation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services AdministrationDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Jyoti Yadav, BDS

    Post graduate institute of dental sciences, Rohtak

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nishi Tanwar, MDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2022

First Posted

October 4, 2022

Study Start

November 1, 2022

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

May 12, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations