Efficacy of Herbal Dentifrice in Treatment of Chronic Periodontitis

NCT06043687 | Completed Phase 3 DMC

• 1 other identifier: DYPV/EC/883/22/B
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• Change in Clinical attachment level

  Change in Clinical attachment level in chronic periodontitis patients following scaling and root planing \& dentifrice usage

  Baseline to 24 weeks

Secondary Outcomes (4)

• Change in Probing pocket depth

  Baseline to 24 weeks

• Change in Plaque Index levels

  Baseline to 24 weeks

• Change in Gingival index levels

  Baseline to 24 weeks

• Change in mean sulcus bleeding index levels

  Baseline to 24 weeks

Study Arms (3)

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.

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.

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.

Drug: Dentifrice Paste

Interventions

Dentifrice Paste DRUG

Scaling and Root planing followed by dentifrice usage

Dentifrice containing Biomin formulation; Dentifrice containing Jasmate formulation; Dentifrice containing placebo formulation

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Dr. D. Y. Patil Dental College & Hospital: lead
• Jasberry Healthcare Pvt. Ltd: collaborator

Study Sites (1)

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

Pune, Maharashtra, 411018, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dharmarajan Gopalakrishnan, MDS, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean, Professor and HOD

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: August 1, 2023
• Primary Completion: October 15, 2023
• Study Completion: December 15, 2023
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)