Furcation DefectsNCT07642895
Effect of Mobile Health on Plaque Control Efficacy in Molars With Furcation Involvement
A study testing Behavioural text messages twice weekly and Standardized oral hygiene instructions in people with Furcation Defects, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Furcation Defects
- What is being tested?
- Behavioural text messages twice weekly and Standardized oral hygiene instructions
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
PGIDS, Rohtak
Rohtak, Haryana, 124001
Nishi Tanwar, +91-8368126310, nsh_tanwar@yahoo.co.in
About this study
Official title: Effect of Mobile Health on Plaque Control Efficacy in Molars With Furcation Involvement: A Randomized Controlled Clinical Trial
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.
Read the detailed description
Furcation involvement (FI) is recognized as one of the most critical factors determining the complexity and prognosis of periodontitis affecting molar teeth. The etiologies of furcation involvement may include anatomic factors, extension of inflammatory periodontal diseases, trauma from occlusion, pulpo-periodontal diseases, and root fracture involving furcation. Several morphological characteristics of roots and furcation lead to poor prognosis of affected teeth. When left untreated, periodontal destruction in furcation areas tends to progress horizontally toward the central portion of the furcation as well as vertically in an apical direction along the root surfaces. Inadequate plaque control in anatomically complex furcation areas causes persistent inflammation which may cause progression of interradicular bone loss.
The prevalence of furcation involvement in mandibular molars was 50% in the population aged 40 years and above. The prevalence of advanced furcation involvement in mandibular first molars showed no significant difference between buccal and lingual sites. Molar teeth with furcation involvement are the most commonly lost.
The anatomical complexity of furcation makes plaque control difficult. Several microbes present in plaque lead to progression of periodontitis and lead to accelerated alveolar bone loss. The use of interdental aids as an adjunct to routine oral hygiene instructions has been advised for plaque control in the furcal areas, as they have been known to decrease subgingival bacterial count and gingival inflammation, and may decrease the possibility of further progress of periodontal disease in these affected sites. However, poor compliance with interdental hygiene measures due to lack of perceived benefits serves as a deterrent to effective plaque control.
Mobile health (mHealth) is defined by the World Health Organization (WHO) as "medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and other wireless devices." India has approximately 1.15 billion mobile phone subscribers, comprising nearly 625 million urban and 524 million rural users, and ranks second globally in mobile phone connectivity, making the integration of mHealth into healthcare delivery highly feasible. mHealth offers real-time communication between patients and healthcare providers, thereby enhancing treatment delivery and follow-up. Evidence from the medical field suggests that mHealth interventions can be effective adjuncts in patient self-management, particularly in chronic conditions such as type 2 diabetes. In dentistry, the use of mHealth as an adjunctive tool in the management of gingivitis and in improving daily self-performed oral hygiene practices has been documented in previous literature.
Research indicates that regular prompts and reminders are effective in promoting and reinforcing healthy habits. The average time required to form a habit is approximately 66 days, with a reported range of 18 to 254 days. In periodontal patients, improvements in oral hygiene performance have been attributed to repetition and reinforcement of oral hygiene instructions. It has been documented that text messaging is effective in promoting behavioral change in the management of chronic diseases. Text messages facilitate behavioral modification and enhance health knowledge by providing guidance, warnings, reminders, positive reinforcement, and feedback. Furthermore, text messaging interventions have demonstrated effectiveness in the prevention and management of conditions such as obesity, smoking, and diabetes.
So, in the view of current literature, the investigator hypothesis that mobile health reinforcements can contribute to improved compliance in oral hygiene behaviors in patients presenting with sites with furcation involvement which may prevent the progression of periodontal disease. To the best of their knowledge, no study till date has been conducted assessing the effectiveness of Mobile Health in sites affected by furcation involvement in improving their oral hygiene after nonsurgical periodontal therapy. So this Randomized controlled Clinical Trial aims to clinically evaluate the effectiveness of Mobile Health in sites affected by furcation involvement in improving efficacy of plaque control after non-surgical periodontal therapy.
Individuals with clinically visible furcation entrance in mandibular molars with Stage III periodontitis will be assigned into 2 groups. Individuals in both the groups will undergo phase I therapy including supragingival and subgingival scaling with a combination of hand scalers and micromini curettes (Hu Friedy) and ultrasonic scaler (EMS Piezon,250, Switzerland) along with standardized oral hygiene instructions and interradicular brushing.
In the experimental group, 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 In the comparator group, standardized oral hygiene instructions and interradicular brushing in furcation involvement individuals will be given at follow up appointments.
Patient Compliance will be assessed by the use of Daily diary method.
- Conditions
- Furcation Defects
- Being tested
- Behavioural text messages twice weekly, Standardized oral hygiene instructions
- Keywords
- FURCATION, FURCATION INVOLVEMENT, MHEALTH
- Medical subject headings
- Furcation Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural text messages twice weeklyBehavioural
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.
Standardized oral hygiene instructionsOther
All participants will recieve standardized oral hygiene instructions including toothbrushing techniques and interdental brushes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioural text messages twice weekly; Other: 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. Receives: Other: Standardized oral hygiene instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 %.
Measured: 6 months
Secondary outcomes (5)
PROBING POCKET DEPTH (PPD)
Probing pocket depth will be measured as the distance from gingival margin to the base of pocket. The probing depth measurements will be assessed using the Periodontal probe. The probe will be inserted in the bottom of pocket and maintained parallel to vertical axis of the tooth. Measurements will be noted at 6 sites of a tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual). Measurements will be rounded to the nearest whole millimeter.
Measured: 6 months
HORIZONTAL PROBING DEPTH (HPD)
Horizontal probing depth will be assessed by probing the furcation in a horizontal direction using a rigid curved probe (e.g. Nabers probe) and measuring the distance from the probe tip to a virtual tangent to the root convexities adjacent to the furcation. Measuring this distance allows assessment of different degrees of FI or the amount of horizontal attachment loss in millimeters (horizontal probing/ clinical attachment level: PAL-H/HCAL).
Measured: 6 months
VERTICAL PROBING DEPTH (HPD)
UNC-15 periodontal probe will be used to record the vertical depth. The probe will be inserted into the periodontal pocket up to the alveolar bone, and the distance from the roof of furcation to the vertical depth of probing (VD) will be measured. All measurements will be recorded nearest to the millimeter.
Measured: 6 months
CLINICAL ATTACHMENT LEVEL(CAL)
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. Distance of base of the pocket from gingival margin, distance of free gingival margin from CEJ will be measured. Afterwards CAL will be calculated based on following criteria. When gingival margin is located on the anatomic crown, the level of attachment is determined by subtracting from the depth of pocket, the distance from the gingival margin to the CEJ. If both are same, the loss of attachment is recorded as zero. When gingival margin coincides with CEJ, the loss of attachment equals to probing pocket depth. When gingival margin is located apical to CEJ, the loss of attachment is greater than probing depth and therefore the distance between CEJ and gingival margin is adde
Measured: 6 months
GINGIVAL INDEX (GI)
Gingival index by Loe and Silness (1963) will be used to assess severity of gingival inflammation. Measurements will be taken at 4 sites of each tooth (buccal, lingual, mesial and distal).
0- Absence of inflammation.
- Mild inflammation - slight change in color and little change in texture.
- Moderate inflammation - moderate glazing, redness, oedema. and hypertrophy. Bleeding on pressure.
- Severe inflammation - marked redness and hypertrophy. Tendency to spontaneous bleeding. Ulceration.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Furcation DefectsStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642895
- Sponsor's protocol ID
- Saurav Singh Perio 26/61
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mobile Health on Plaque Control Efficacy in Molars With Furcation Involvement: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07642895
- Acronym / sponsor ID
- Saurav Singh Perio 26/61
- Conditions
- Furcation Defects
- Keywords
- FURCATION, FURCATION INVOLVEMENT, MHEALTH
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Jun 2026 (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.
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.
Detailed description
Furcation involvement (FI) is recognized as one of the most critical factors determining the complexity and prognosis of periodontitis affecting molar teeth. The etiologies of furcation involvement may include anatomic factors, extension of inflammatory periodontal diseases, trauma from occlusion, pulpo-periodontal diseases, and root fracture involving furcation. Several morphological characteristics of roots and furcation lead to poor prognosis of affected teeth. When left untreated, periodontal destruction in furcation areas tends to progress horizontally toward the central portion of the furcation as well as vertically in an apical direction along the root surfaces. Inadequate plaque control in anatomically complex furcation areas causes persistent inflammation which may cause progression of interradicular bone loss.
The prevalence of furcation involvement in mandibular molars was 50% in the population aged 40 years and above. The prevalence of advanced furcation involvement in mandibular first molars showed no significant difference between buccal and lingual sites. Molar teeth with furcation involvement are the most commonly lost.
The anatomical complexity of furcation makes plaque control difficult. Several microbes present in plaque lead to progression of periodontitis and lead to accelerated alveolar bone loss. The use of interdental aids as an adjunct to routine oral hygiene instructions has been advised for plaque control in the furcal areas, as they have been known to decrease subgingival bacterial count and gingival inflammation, and may decrease the possibility of further progress of periodontal disease in these affected sites. However, poor compliance with interdental hygiene measures due to lack of perceived benefits serves as a deterrent to effective plaque control.
Mobile health (mHealth) is defined by the World Health Organization (WHO) as "medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and other wireless devices." India has approximately 1.15 billion mobile phone subscribers, comprising nearly 625 million urban and 524 million rural users, and ranks second globally in mobile phone connectivity, making the integration of mHealth into healthcare delivery highly feasible. mHealth offers real-time communication between patients and healthcare providers, thereby enhancing treatment delivery and follow-up. Evidence from the medical field suggests that mHealth interventions can be effective adjuncts in patient self-management, particularly in chronic conditions such as type 2 diabetes. In dentistry, the use of mHealth as an adjunctive tool in the management of gingivitis and in improving daily self-performed oral hygiene practices has been documented in previous literature.
Research indicates that regular prompts and reminders are effective in promoting and reinforcing healthy habits. The average time required to form a habit is approximately 66 days, with a reported range of 18 to 254 days. In periodontal patients, improvements in oral hygiene performance have been attributed to repetition and reinforcement of oral hygiene instructions. It has been documented that text messaging is effective in promoting behavioral change in the management of chronic diseases. Text messages facilitate behavioral modification and enhance health knowledge by providing guidance, warnings, reminders, positive reinforcement, and feedback. Furthermore, text messaging interventions have demonstrated effectiveness in the prevention and management of conditions such as obesity, smoking, and diabetes.
So, in the view of current literature, the investigator hypothesis that mobile health reinforcements can contribute to improved compliance in oral hygiene behaviors in patients presenting with sites with furcation involvement which may prevent the progression of periodontal disease. To the best of their knowledge, no study till date has been conducted assessing the effectiveness of Mobile Health in sites affected by furcation involvement in improving their oral hygiene after nonsurgical periodontal therapy. So this Randomized controlled Clinical Trial aims to clinically evaluate the effectiveness of Mobile Health in sites affected by furcation involvement in improving efficacy of plaque control after non-surgical periodontal therapy.
Individuals with clinically visible furcation entrance in mandibular molars with Stage III periodontitis will be assigned into 2 groups. Individuals in both the groups will undergo phase I therapy including supragingival and subgingival scaling with a combination of hand scalers and micromini curettes (Hu Friedy) and ultrasonic scaler (EMS Piezon,250, Switzerland) along with standardized oral hygiene instructions and interradicular brushing.
In the experimental group, 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 In the comparator group, standardized oral hygiene instructions and interradicular brushing in furcation involvement individuals will be given at follow up appointments.
Patient Compliance will be assessed by the use of Daily diary method.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Messages + Oral hygiene Instructions | Experimental | Behavioral: Behavioural text messages twice weekly, Other: Standardized oral hygiene instructionsRegular messages twice a week will be sent to the individuals reminding the individuals for standardized oral hygiene instructions and interradicular brushing in furcation involvement. |
| Oral hygiene Instructions | Active comparator | Other: Standardized oral hygiene instructionsStandardized oral hygiene instructions and interradicular brushing in furcation involvement individuals will be given at follow up appointments. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Behavioural text messages twice weeklyRegular 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. | Behavioural | Messages + Oral hygiene Instructions |
| Standardized oral hygiene instructionsAll participants will recieve standardized oral hygiene instructions including toothbrushing techniques and interdental brushes. | Other | Messages + Oral hygiene Instructions, Oral hygiene Instructions |
Primary outcome
Plaque Index
Time frame: 6 months
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.
Bleeding on probing
Time frame: 6 months
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 %.
5 secondary outcomes
PROBING POCKET DEPTH (PPD)
Time frame: 6 months
HORIZONTAL PROBING DEPTH (HPD)
Time frame: 6 months
VERTICAL PROBING DEPTH (HPD)
Time frame: 6 months
CLINICAL ATTACHMENT LEVEL(CAL)
Time frame: 6 months
GINGIVAL INDEX (GI)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioural text messages twice weekly and Standardized oral hygiene instructions in people with Furcation Defects, 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 3 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: opening soon, as of the sponsor's last update on 11 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SAURAV SINGH (+91-8851984435, sauravsinghpal.2000@gmail.com), 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?
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 11 Jun 2026.