Propolis as a Treatment for Cervical Dentin Hypersensitivity
Condition: Dental Root Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

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.
    

Detailed description: 
      Preparation of the materials 10 milligrams of Sodium Fluoride powder was mixed with 500 ml of
      distilled water to attain 500 ml of 2% concentrated Sodium Fluoride solution. Commercially
      available Acidulated Phosphate Fluoride was used at 1.23% concentration. Preparation of
      propolis: Commercially available raw Indian propolis in wax form was obtained from Hi-Tech
      Natural Product India Limited, New Delhi, India. 10% propolis was prepared after mixing with
      of 70% ethanol and distilled water based on the method described previously. Propolis and
      ethanol mixture was allowed to stay in a dark place for two weeks. The mixture was stirred
      everyday intermittently for two weeks. Later the mixture was strained twice using filter
      paper (Whatman International Ltd. England) to remove impurities. Propolis in general is
      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 the dark amber-colored
      bottle without any preservatives.

      Study Design The trial was designed after multiple discussions among the authors and strictly
      followed the guidelines of CONSORT (Consolidated standards of reporting trials). It was a
      single centered, parallel, and double-blinded randomized clinical trial, approved by an
      institutional ethical review board and thesis protocol was registered in concerned medical
      university. Centralized computer-generated randomization was done without any restrictions.
      Randomization codes were kept sealed and managed by the central pharmacy to follow the
      allocation concealment. The DH measurements were performed by two blinded examiners (NMB and
      NRR), and averages were noted at each time interval. Each time, while checking, a new sheet
      of paper was given to the examiners to record the measurements, and to hide the old measures,
      to prevent bias. Interventions were carried out by another blinded author (TS). Cronbach's
      Alpha for inter-examiner reliability was found to be 0.92 and intra-examiner reliability 0.85
      and 0.82 for examiner 1 and 2 respectively.

      Study Participants Consecutive patients who visited the Department of Periodontology; from
      April 2019 to August 2020, with the DH as a chief complaint, with an age range of 25-60 years
      were invited to join in the study. Participating in the study was purely voluntary. Written
      informed consent was taken from each patient. The willing patients were assessed for
      following the necessary eligibility criteria.

      Patients included were: 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. However, patients excluded were: 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.

      Patients were allocated to three test groups after randomization. Oral prophylaxis was done
      in all three groups; baseline DH levels were then evaluated.

      Application of desensitizing agents Vaseline was generally applied all over the gingiva and
      mucosa with a cotton pellet to foil the soft tissues from any undesired effect. Desensitizers
      used in test groups were 10% Propolis, 2% Sodium Fluoride, and 1.23% Acidulated Phosphate
      Fluoride for the first, second, and third group, respectively. A respective desensitizer, the
      pea-sized quantity was smeared over the test tooth. Subsequently, Iontophoresis was applied
      immediately in all three groups. The desensitizing agent was administered at two intervals,
      immediately after oral prophylaxis and at the 14th-day visit.

      Application of Iontophoresis Iontophoresis equipment (Medical S.R.L., Italy) was used in this
      study. The procedure includes application of electric current on the test tooth for
      penetration of ions through dentinal tubules. Based on the patient arch size, the
      corresponding tray size is selected. A sponge used over the tray for placing the
      desensitizer. A particular desensitizer is applied in the sponge based on the respective
      subject's study group. The tray along with a sponge is then positioned in the patient mouth.
      The patient was instructed to hold the positive electrode of the iontophoresis unit with
      his/her palm. The negative electrode was connected to the metal plate in the tray. The unit
      is now switched on, and a current of 2 milliamperes is applied for one minute, based on
      manufacturer specifications. After one minute, the unit is switched off, and the same
      procedure is employed on the opposing arch. The patient is advised not to drink/eat or rinse
      his mouth for another half an hour.

      Assessing clinical parameters Tactile, air blast and cold water stimuli were applied in the
      given order. Reduction of the DH (primary outcome) was traced at the baseline, immediately
      after ultrasonic scaling, and shortly after desensitizer application, postoperative 14 days
      before and after application of desensitizer, and postoperative 28 days without any
      application. A careful check for any adverse reactions with desensitizers was done at all
      intervals. The tactile test was done with the help of pressure sensitive probe. Immediate
      apical to the cementoenamel junction, the probe was moved from distal to mesial direction,
      graded as 1-10 on the visual analogue scale (VAS) based on the patient's discomfort. A
      four-graded Schiff's scale measured air stimulus. Zero was taken as no response, one as a
      response is noticed but the subject does not request for discontinuation of the stimulus, two
      as a response is noticed and the subject requests for discontinuation of the stimulus, three
      as pain is seen and the subject requests for discontinuation of the stimulus. A cold-water
      test was done with cold water application drop by drop with a disposable syringe, measured
      with VAS.

      All the study subjects across study groups were provided with Colgate Regular Toothpaste and
      a soft-bristle toothbrush. The study subjects were demonstrated modified Stillman's
      toothbrushing technique on an oversized tooth model and instructed to brush once in the
      morning and once before sleep at night for 2-3 minutes from the first day till the end of the
      follow-up period.
    

Intervention name(s): desensitizing agents -10% Propolis
Intervention type(s): Combination Product
Intervention description(s): 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.
Intervention MeSH terms: Propolis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dental calculus; Dentine sensitivity; Gingival recession