Propolis as a Treatment for Cervical Dentin Hypersensitivity

NCT05588518 | Completed

• 1 other identifier: IRB/KKUCOD/ETH/2018-19/112
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Fluoridated desensitizers the frequently used for the treatment of dentin hypersensitivity (DH) with Iontophoresis. This study aimed to evaluate and compare the immediate and long-term effects of 10% Propolis with 2% sodium fluoride and 1.23% acidulated phosphate fluoride when applied along with Iontophoresis for the treatment of cervical dentin hypersensitivity (DH). Single-center, parallel, and double-blinded randomized clinical trials were conducted on systemically healthy patients, complaining about DH, with at least two sites. 10% propolis, 2% Sodium Fluoride and 1.23% Acidulated Phosphate Fluoride were used as desensitizers along with the Iontophoresis. After applying specific stimuli any decrease in DH was measured at baseline before and after application, on the 14th day after use, and at 28th-day post-intervention time intervals.

Conditions

Dental Root Sensitivity

Keywords

Dental calculus; Dentine sensitivity; Gingival recession

Outcome Measures

Primary Outcomes (1)

• reduced dentin hypersensitivity

  significant reduction in dentin hypersensitivity

  baseline (0 day) to 28th day

Study Arms (3)

test group-1- 10% propolis

EXPERIMENTAL

10% propolis desensitizer, a pea-sized quantity was smeared over the test tooth. Subsequently, Iontophoresis was applied immediately. The desensitizing agent was administered at two intervals, immediately after oral prophylaxis and at the 14th-day visit.

Combination Product: desensitizing agents -10% Propolis

test group -2- 2% sodium fluoride

ACTIVE COMPARATOR

2% sodium fluoride desensitizer, a pea-sized quantity was smeared over the test tooth. Subsequently, Iontophoresis was applied immediately. The desensitizing agent was administered at two intervals, immediately after oral prophylaxis and at the 14th-day visit.

Combination Product: desensitizing agents -10% Propolis

test group-3- 1.23% acidulated phosphate fluoride

ACTIVE COMPARATOR

1.23% acidulated phosphate fluoride desensitizer, a pea-sized quantity was smeared over the test tooth. Subsequently, Iontophoresis was applied immediately. The desensitizing agent was administered at two intervals, immediately after oral prophylaxis and at the 14th-day visit.

Combination Product: desensitizing agents -10% Propolis

Interventions

desensitizing agents -10% Propolis COMBINATION_PRODUCT

10% propolis was prepared after mixing with 70% ethanol and distilled water based on the method described previously. Propolis and ethanol mixture was allowed to stay in dark place for two weeks. The mixture was stirred everyday intermittently for two weeks. Later the mixture was strained twice using filter paper to remove impurities. Propolis in general are fairly stable without losing its antibacterial properties for over 12 months when stored without direct sunlight and at cool temperatures. Alcohol based extracts will have extended shelf life and hence ethanol-extracted propolis prepared was stored in dark amber colored bottle without any preservatives.

test group -2- 2% sodium fluoride; test group-1- 10% propolis; test group-3- 1.23% acidulated phosphate fluoride

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically healthy (based on the medical and drug history.), needing oral prophylaxis with moderate calculus (subjects who have moderately poor oral hygiene and needs teeth cleaning), at least two non-adjacent hypersensitive teeth with Schiff scale score as \>1 with air blast stimulus and availability of a minimum of 10 evaluable natural teeth excluding third molars.

You may not qualify if:

• Undergoing orthodontic therapy, undertreatment for DH/using desensitizing dentifrice, pregnant women, any history of periodontal treatment before three months, any history of asthma, allergic to honey bee products and pollen, teeth with dental caries, attrition, abrasion, erosion, and lack of vitality.

Sponsors & Collaborators

• King Khalid University: lead

Study Sites (1)

College of Dentistry King Khalid University

Abhā, 'Asir Region, 65412, Saudi Arabia

Location

Related Publications (3)

• Purra AR, Mushtaq M, Acharya SR, Saraswati V. A comparative evaluation of propolis and 5.0% potassium nitrate as a dentine desensitizer: A clinical study. J Indian Soc Periodontol. 2014 Jul;18(4):466-71. doi: 10.4103/0972-124X.138695.

  PMID: 25210261 BACKGROUND

• Torwane NA, Hongal S, Goel P, Chandrashekar BR, Jain M, Saxena E. A clinical efficacy of 30% ethenolic extract of Indian propolis and Recaldent in management of dentinal hypersensitivity: A comparative randomized clinical trial. Eur J Dent. 2013 Oct;7(4):461-468. doi: 10.4103/1305-7456.120675.

  PMID: 24932122 BACKGROUND

• Madhavan S, Nayak M, Shenoy A, Shetty R, Prasad K. Dentinal hypersensitivity: A comparative clinical evaluation of CPP-ACP F, sodium fluoride, propolis, and placebo. J Conserv Dent. 2012 Oct;15(4):315-8. doi: 10.4103/0972-0707.101882.

  PMID: 23112475 BACKGROUND

MeSH Terms

Conditions

Dental Calculus; Dentin Sensitivity; Gingival Recession

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Periodontal Atrophy

Study Officials

• Raghavendra R Nagate, MDS

  King Khalid University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 15, 2022
• First Posted: October 20, 2022
• Study Start: April 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: August 1, 2020
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)