Chronic PeriodontitisPhase 3NCT06043687

Efficacy of Herbal Dentifrice in Treatment of Chronic Periodontitis

A Phase 3 study testing Dentifrice Paste in people with Chronic Periodontitis, run by Dr. D. Y. Patil Dental College & Hospital at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 50 years
Conditions the study is for: Chronic Periodontitis
What is being tested?: Dentifrice Paste
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 75 participants
Where: 1 siteIndia
Study dates: 1 Aug 2023to 15 Dec 2023
Phase: Phase 3
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 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

The patient should be in good general health as determined by the Investigator/ medical expert;
The patient should agree not to participate in any other oral/dental product studies during the course of this study;
The patient should agree to delay any dental treatment until the study has been completed;
The patient should agree to abstain from the use of any non-study oral hygiene products;
The patient should exhibit adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect);
The patient should agree to return for all scheduled visits and follow study procedures;

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The patient should have a minimum of 20 teeth
The periodontal status of the patient should be Mild to moderate periodontitis (AAP classification 1999)
The oral status of the patient should be as follows:
Plaque index (Silness \& Löe 1964)>2 Gingival Index (Löe and Silness 1963) >1.5 Modified Sulcus Bleeding Index (Mombelli et al 1987) >1 PPD > 4mm

Who cannot join

Presence of any condition, abnormality or situation at baseline that in the opinion of the Principal Investigator may preclude the volunteer's ability to comply with study requirements, including completion of the study or the quality of the data
Pregnant females
Patients having history of Tobacco use
Patients with Sjögren's disease
Patients having immune deficiency diseases, i.e., HIV or AIDS
Patients with poorly controlled diabetes mellitus

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Patients taking anti TNF-alpha medication for rheumatoid arthritis
Patients taking anti-inflammatory, analgesic, or psychotropic drugs,
Patients having self-reported eating disorders, uncontrolled gastroesophageal reflux disease (GERD or Acid Reflux), excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity;
Patients with a history or presence of kidney disorders, kidney stones, celiac disease, inflammatory bowel disease (ulcerative colitis or Crohn's disease), chronic pancreatitis, have had intestinal or weight-loss surgery, or if have stomach or intestinal problems that keep them from absorbing certain foods or nutrients;
The teeth will be excluded from study measurements if they have deep, defective, or facial restorations; have full crowns, extensive caries, cracked enamel, or are abutment teeth for fixed or removable prosthesis;
The teeth having endo-perio lesion.

Trial locations and contacts

1 site in 1 country.

India1 site

Dr. D Y Patil Dental College and Hospital, Pimpri, Pune
Pune, Maharashtra, 411018

Other trials in India

About this study

Official title: Clinical Efficacy of Two Different Dentifrice Formulations in Treatment of Chronic Periodontitis

The study will be a single center, longitudinal prospective, triple blind (investigators, patients and statistician), randomized design. After informed consent, a target population of about 75 healthy adult volunteers with periodontitis will be included in the study. Patients will be randomized and categorized into three experimental groups each containing 25 patients. The randomization process will be carried out by use of sequentially numbered opaque sealed envelopes (SNOSE method).The recording of all the soft tissues data plaque index, gingival index, the modified sulcus bleeding index and the periodontal probing depth and clinical attachment level will be carried out at baseline, 4 weeks, 8 weeks, 12 weeks and will be maintained till 24 weeks for efficacy and safety evaluation.

Read the detailed description

Patients will be instructed to brush twice daily. Patients will be instructed to apply at least a 1-inch strip of the toothpaste onto a soft toothbrush and to brush thoroughly for 2 minutes and expectorate. All patients will be instructed to use only the assigned products and refrain from other dentifrice or mouth-rinse during the trial but will be allowed to continue their normal oral hygiene practices. Patients will use the assigned product for a period of 24 weeks for assessment of the efficacy and safety in periodontitis patients.

A complete and detail oral examination will then be conducted to evaluate the oral and perioral region, including soft tissues. Patients will return at study location at 4 weeks, 8 weeks, 12 weeks and 24 weeks for the soft-tissue assessment using the plaque index, gingival index, the modified sulcus bleeding index and the periodontal probing depth and clinical attachment level.

The following objectives will be assessed -

Objectives:

To assess efficacy and safety of Jasmate toothpaste preparation over a period of 24 weeks.
To evaluate the change in PI, GI, mSBI, PPD, CAL, in chronic periodontitis patients following scaling and root planing at 4 weeks, 8 weeks, 12 weeks and 24 weeks compared to baseline using Jasmate toothpaste preparation.
To evaluate the change in PI, GI, mSBI, PPD, CAL, in chronic periodontitis patients following scaling and root planing at 4 weeks, 8 weeks, 12 weeks and 24 weeks compared to baseline using BioMin Ftoothpaste preparation.
To compare the change in PI, GI, mSBI, PPD, CAL in chronic periodontitis patients following scaling and root planing at 4 weeks, 8 weeks, 12 weeks and 24 weeks using Jasmate toothpaste preparation and BioMin Ftoothpaste preparation.

Conditions: Chronic Periodontitis
Being tested: Dentifrice Paste
Medical subject headings: Chronic Periodontitis

What participants receive

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

Dentifrice PasteDrug
Scaling and Root planing followed by dentifrice usage

Study groups in NCT06043687
Study group	Role	What they receive
Dentifrice containing Jasmate formulation	Experimental	Patients will be instructed to brush twice daily. Patients will be instructed to apply at least a 1-inch strip of the Jasmate formulation toothpaste onto a soft toothbrush and to brush thoroughly for 2 minutes and expectorate. All patients will be instructed to use only the assigned products and refrain from other dentifrice or mouth-rinse during the trial but will be allowed to continue their normal oral hygiene practices. Patients will use the assigned product for a period of 24 weeks for assessment of the efficacy and safety in periodontitis patients. Receives: Drug: Dentifrice Paste
Dentifrice containing Biomin formulation	Active comparator	Patients will be instructed to brush twice daily. Patients will be instructed to apply at least a 1-inch strip of the Biomin formulation toothpaste onto a soft toothbrush and to brush thoroughly for 2 minutes and expectorate. All patients will be instructed to use only the assigned products and refrain from other dentifrice or mouth-rinse during the trial but will be allowed to continue their normal oral hygiene practices. Patients will use the assigned product for a period of 24 weeks for assessment of the efficacy and safety in periodontitis patients. Receives: Drug: Dentifrice Paste
Dentifrice containing placebo formulation	Placebo comparator	Patients will be instructed to brush twice daily. Patients will be instructed to apply at least a 1-inch strip of the Placebo formulation toothpaste onto a soft toothbrush and to brush thoroughly for 2 minutes and expectorate. All patients will be instructed to use only the assigned products and refrain from other dentifrice or mouth-rinse during the trial but will be allowed to continue their normal oral hygiene practices. Patients will use the assigned product for a period of 24 weeks for assessment of the efficacy and safety in periodontitis patients. Receives: Drug: Dentifrice Paste

What is being measured

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

Change in Clinical attachment level
Change in Clinical attachment level in chronic periodontitis patients following scaling and root planing \& dentifrice usage
Measured: Baseline to 24 weeks

Secondary outcomes (4)

Change in Probing pocket depth
Change in Probing pocket depth in chronic periodontitis patients following scaling and root planing \& dentifrice usage
Measured: Baseline to 24 weeks
Change in Plaque Index levels
Change in Plaque index levels in chronic periodontitis patients following scaling and root planing \& dentifrice usage
Measured: Baseline to 24 weeks
Change in Gingival index levels
Change in Gingival index levels in chronic periodontitis patients following scaling and root planing \& dentifrice usage
Measured: Baseline to 24 weeks
Change in mean sulcus bleeding index levels
Change in mean sulcus bleeding index levels in chronic periodontitis patients following scaling and root planing \& dentifrice usage
Measured: Baseline to 24 weeks

Timeline

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

1 Aug 202315 Dec 2023

First posted21 Sep 2023
Study start1 Aug 2023
Primary completion15 Oct 2023
Study completion15 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic PeriodontitisStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06043687
Sponsor's protocol ID: DYPV/EC/883/22/B
Status last verified: Oct 2024
First submitted: 12 Sep 2023
Last updated: 8 Oct 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Recruiting
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
Single-visit, Periapical Periodontitis

All Chronic Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Efficacy of Two Different Dentifrice Formulations in Treatment of Chronic Periodontitis
ClinicalTrials.gov ID: NCT06043687
Acronym / sponsor ID: DYPV/EC/883/22/B
Conditions: Chronic Periodontitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: Dr. D. Y. Patil Dental College & HospitalUniversity, hospital or other
Collaborators: Jasberry Healthcare Pvt. Ltd
Study start: 1 Aug 2023 (actual)
Primary completion: 15 Oct 2023 (actual)
Study completion: 15 Dec 2023 (actual)
First posted: 21 Sep 2023 (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.

Detailed description

The following objectives will be assessed -

Objectives:

To assess efficacy and safety of Jasmate toothpaste preparation over a period of 24 weeks.
To evaluate the change in PI, GI, mSBI, PPD, CAL, in chronic periodontitis patients following scaling and root planing at 4 weeks, 8 weeks, 12 weeks and 24 weeks compared to baseline using Jasmate toothpaste preparation.
To evaluate the change in PI, GI, mSBI, PPD, CAL, in chronic periodontitis patients following scaling and root planing at 4 weeks, 8 weeks, 12 weeks and 24 weeks compared to baseline using BioMin Ftoothpaste preparation.
To compare the change in PI, GI, mSBI, PPD, CAL in chronic periodontitis patients following scaling and root planing at 4 weeks, 8 weeks, 12 weeks and 24 weeks using Jasmate toothpaste preparation and BioMin Ftoothpaste preparation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Dentifrice containing Jasmate formulation	Experimental	Drug: Dentifrice PastePatients will be instructed to brush twice daily. Patients will be instructed to apply at least a 1-inch strip of the Jasmate formulation toothpaste onto a soft toothbrush and to brush thoroughly for 2 minutes and expectorate. All patients will be instructed to use only the assigned products and refrain from other dentifrice or mouth-rinse during the trial but will be allowed to continue their normal oral hygiene practices. Patients will use the assigned product for a period of 24 weeks for assessment of the efficacy and safety in periodontitis patients.
Dentifrice containing Biomin formulation	Active comparator	Drug: Dentifrice PastePatients will be instructed to brush twice daily. Patients will be instructed to apply at least a 1-inch strip of the Biomin formulation toothpaste onto a soft toothbrush and to brush thoroughly for 2 minutes and expectorate. All patients will be instructed to use only the assigned products and refrain from other dentifrice or mouth-rinse during the trial but will be allowed to continue their normal oral hygiene practices. Patients will use the assigned product for a period of 24 weeks for assessment of the efficacy and safety in periodontitis patients.
Dentifrice containing placebo formulation	Placebo comparator	Drug: Dentifrice PastePatients will be instructed to brush twice daily. Patients will be instructed to apply at least a 1-inch strip of the Placebo formulation toothpaste onto a soft toothbrush and to brush thoroughly for 2 minutes and expectorate. All patients will be instructed to use only the assigned products and refrain from other dentifrice or mouth-rinse during the trial but will be allowed to continue their normal oral hygiene practices. Patients will use the assigned product for a period of 24 weeks for assessment of the efficacy and safety in periodontitis patients.

Who may qualify

Ages: 30 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (10 listed)

The patient should be in good general health as determined by the Investigator/ medical expert;
The patient should agree not to participate in any other oral/dental product studies during the course of this study;
The patient should agree to delay any dental treatment until the study has been completed;
The patient should agree to abstain from the use of any non-study oral hygiene products;
The patient should exhibit adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect);

Key exclusion criteria (12 listed)

Presence of any condition, abnormality or situation at baseline that in the opinion of the Principal Investigator may preclude the volunteer's ability to comply with study requirements, including completion of the study or the quality of the data
Pregnant females
Patients having history of Tobacco use
Patients with Sjögren's disease
Patients having immune deficiency diseases, i.e., HIV or AIDS

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
Dentifrice PasteScaling and Root planing followed by dentifrice usage	Drug	Dentifrice containing Biomin formulation, Dentifrice containing Jasmate formulation, Dentifrice containing placebo formulation

Primary outcome

Change in Clinical attachment level
Time frame: Baseline to 24 weeks
Change in Clinical attachment level in chronic periodontitis patients following scaling and root planing \& dentifrice usage

4 secondary outcomes

Change in Probing pocket depth
Time frame: Baseline to 24 weeks
Change in Plaque Index levels
Time frame: Baseline to 24 weeks
Change in Gingival index levels
Time frame: Baseline to 24 weeks
Change in mean sulcus bleeding index levels
Time frame: Baseline to 24 weeks

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 8 Oct 2024.
Individual participant dataSharing planned: No

Related trials for Chronic Periodontitis

Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Recruiting
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
Single-visit, Periapical Periodontitis

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.

Dharmarajan Gopalakrishnan, MDS, PhD principal investigator

Dr. D Y Patil Dental College and Hospital, Pimpri, Pune

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dentifrice Paste in people with Chronic Periodontitis, run by Dr. D. Y. Patil Dental College & Hospital 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 10 inclusion and 12 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 8 Oct 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 in Clinical attachment level (time frame: Baseline to 24 weeks). 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 NCT06043687.

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 8 Oct 2024.