NCT07642895

Brief Summary

Furcation involvement (FI) refers to a condition in which the progression of the periodontal disease process invades the bifurcation and trifurcation of multirooted teeth. Furcation involvement, present a clinical challenge due to its anatomic complexity and reduced access for adequate plaque control which may leads to further periodontal breakdown. Consequently, maintenance of adequate oral hygiene is critical in these sites. It has been shown that poor oral hygiene, together with the persistence of periodontal risk factors, leads to further disease progression, treatment failure, and disease recurrence. Mobile health can serve as a valuable adjunctive approach by aiding in behavioral reinforcement through real-time reminders. With widespread mobile phone usage in India, mHealth interventions are feasible. The role of mHealth in management of furcation involved sites has still not been explored. Therefore, this randomized controlled clinical trial aims to evaluate the effectiveness of mobile health reinforcements in improving plaque control efficacy at in furcation involved sites following non-surgical periodontal therapy, with the potential to enhance patient compliance and prevent further disease progression and disease recurrence.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jun 2026Dec 2027

Study Start

First participant enrolled

June 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

1.2 years

First QC Date

June 2, 2026

Last Update Submit

June 9, 2026

Conditions

Keywords

FURCATIONFURCATION INVOLVEMENTMHEALTH

Outcome Measures

Primary Outcomes (2)

  • Plaque Index

    Plaque index by Silness and Loe (1964) will be used for assessment of plaque.Score range of this index is from 0 to 3.Score 0 means good oral hygiene and score 3 means poor oral hygiene.

    6 months

  • Bleeding on probing

    It will be measured by walking the periodontal probe at 6 sites of each tooth (mesio-buccal, mid-buccal, disto-buccal, mesio- lingual, mid-lingual and disto-lingual). It will be recorded as 1 (present) if it occurred within 15 sec of probing and 0 (absent) if no bleeding occurred. It will be calculated in %.

    6 months

Secondary Outcomes (5)

  • PROBING POCKET DEPTH (PPD)

    6 months

  • HORIZONTAL PROBING DEPTH (HPD)

    6 months

  • VERTICAL PROBING DEPTH (HPD)

    6 months

  • CLINICAL ATTACHMENT LEVEL(CAL)

    6 months

  • GINGIVAL INDEX (GI)

    6 months

Study Arms (2)

Messages + Oral hygiene Instructions

EXPERIMENTAL

Regular messages twice a week will be sent to the individuals reminding the individuals for standardized oral hygiene instructions and interradicular brushing in furcation involvement.

Behavioral: Behavioural text messages twice weeklyOther: Standardized oral hygiene instructions

Oral hygiene Instructions

ACTIVE COMPARATOR

Standardized oral hygiene instructions and interradicular brushing in furcation involvement individuals will be given at follow up appointments.

Other: Standardized oral hygiene instructions

Interventions

Regular messages twice a week will be sent to the individuals reminding the individuals for standardized oral hygiene instructions and interradicular brushing in furcation involvement. Individuals will be asked to respond to the messages.

Messages + Oral hygiene Instructions

All participants will recieve standardized oral hygiene instructions including toothbrushing techniques and interdental brushes.

Messages + Oral hygiene InstructionsOral hygiene Instructions

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Systemically healthy individuals with clinically visible furcation entrance in mandibular molars in Stage III periodontitis
  • Horizontal bone loss extent ≥ 3mm29 and vertical bone loss ( Subclass A/B)30
  • Access to mobile phone

You may not qualify if:

  • Presence of systemic diseases that could influence the outcome of periodontal therapy (Diabetes mellitus, Hypertension)
  • Smoking/alcohol consumption
  • Teeth with Grade II/III mobility
  • History of periodontal treatment or antibiotic therapy in the last 6 months
  • Non-vital and carious teeth to be restored
  • Physically and mentally impaired patients
  • Furcation involvement with cervical enamel projections, enamel pearls and bifurcation ridges

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIDS, Rohtak

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Furcation Defects

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 11, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations