EVALUATION OF VARIOUS TREATMENT MODALITIES FOR RECURRENT APHTHOUS ULCER A RANDOMIZED CLINICAL CONTROLLED STUDY

Recurrent aphthous stomatitis are common painful oral ulcers  categorized as minor major herpetiform. Etiology involves stress immunologic hormonal hereditary environmental factors Treatment includes Honey-Turmeric mix cap. Pre-pro biotic Topical Triamcinolone

Study Aims & Objectives

To compare efficacy of Oral probiotics Topical steroids Topical application of turmeric powder with honey in management of recurrent aphthous ulcer

The objectives are

To assess the efficacy of 3 treatment modalities in pain, burning sensation and reduction in size

To evaluate the most effective treatment plan for healing of  recurrent aphthous ulcer

Methodology

·         Study Location Department of Oral Medicine and Radiology Government Dental College and Hospital Ahmedabad

·         Probable estimated time to complete the study  2 years

·         Sample size with calculation formula Statistician Certificate is mandatory  Total 138  patients 46 in each group analysis done using A priori

·         Inclusion and Exclusion Criteria

INCLUSION CRITERIA

Subjects of both gender attending daily routine OPD

Subjects suffering from recurrent major & minor aphthous ulcer

Subjects willing to participate & giving informed consent

Patients not taking any other medications

EXCLUSION CRITERIA

·         Recurrent aphthous ulcer in an inaccessible area

·         Pregnant or lactating women

·         Patient already undergoing treatment for ulcer

·         Ulcer associated with other oro mucosal lesion or ulcer

·         Patients with systemic diseases like Bechet syndrome Sweet syndrome periodic fever adenitis pharyngitis aphthous ulcer PFAPA Reiter syndrome Crohn’s disease Gluten sensitive enteropathy etc

·         Subjects hypersensitive to agents used in this trial

·         Armamentarium and Methodology

·         Armamentarium

Diagnostic instruments

Williams Graduated Probe

Informed consent the study is explained followed by which an informed consent is taken from the patient

All patients were given dietary instructions to avoid spicy food & encouraging a bland diet

The patient would be assessed on various parameters like

1.      Pain  or Burning sensation

2.      Lesion size

3.      Number of lesion

4.      Difficulty in chewing or speaking

1.)    Pain The intensity of pain was determined by visual analogue scale VAS

From 1to 10

0         Absent

1to 3 Mild

4to7 Moderate

8to10 Severe

1        Burning sensation: Burning sensation was recorded using VAS as follows

0to3Mild Burning sensation

4to7Moderate Burning sensation

8to10 severe Burning sensation

Size of ulcer The size of ulcer was measured using Williams graduated probe

Number of ulcer

Difficulty in chewing or speaking yes or  no

 Group 1 A monotherapy of microbiome pre probiotic orally

Participants were advised to take capsule thrice daily with food for a week.

 Group 2 Topical application of mixture of turmeric powder and honey

Participants were advised to freshly prepare (at the time of every application) mixture of ¼ tea spoon of turmeric powder & ¼ tea spoon of honey, apply thrice daily over and around 1 cm of each ulcer with cotton applicator tip & advised not to eat or drink or spit for next 30 mins.

Also instructed to use clean utensils while preparing mixture & apply mixture after gargling.

 Group 3 Topical application of 0.1% triamcinolone acetonide

Participants were advised to apply thrice daily over and around 1 cm of each ulcer by cotton applicator tip & advised not to eat or drink for next 30 mins

 ·         Observational Parameters VAS score for pain burning sensation and measuring size of ulcer on 0 4 & 7 day

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Concluding Remarks or  expected outcomes

The results will compare between the efficacy and  rapidity to response of all the three different treatment modalities resulting in reduction in size of ulcer pain and in burning sensation with reduction in frequency of recurrence.