EVALUATING THE EFFECT OF ROYAL JELLY SOLUTION AS A SUBGINGIVAL IRRIGANT-A RANDOMIZED CONTROLLED CLINICAL TRIAL

AIM

Toevaluate the clinical effect of subgingival irrigation with royal jelly inmanagement of periodontal disease

OBJECTIVES

·       Toevaluate the effect of subgingival irrigation with  royal jelly solution by means of clinicalparameters

·       Toevaluate the effect of subgingival irrigation with saline solution by means of clinical parameters

·       Toevaluate the effect of subgingival irrigation with distilled water by means of clinical parameters

·       Tocompare the effects of subgingival irrigation for these three agents by meansof clinical parameters

JUSTIFICATIONFOR THE STUDY

Thepurpose of the study is mainly to evaluate clinical effect of new apitherapyproduct royal jelly solution as a subgingival irrigant in reducing clinicalsigns of periodontitis

MATERIALS& METHODS

This studyincludes 30 medically healthy individuals with chronic periodontitis undergoingperiodontal therapy at the department of Periodontics in Vivekananda DentalCollege will be randomly selected. Written consent from the participants willbe collected for the inclusion of this study

ü  Numberof patients:30

CRITERIA FORGROUPING

§  GROUP A: SUBGINGIVAL IRRIGATION WITH ROYAL JELLY SOLUTION

§  GROUP B: SUBGINGIVAL IRRGATION WITH SALINE SOLUTION

§  GROUP C: SUBGINGIVAL IRRIGATION WITH DISTILLED WATER

INCLUSION CRITERIA

Ø  Two or more sites with periodontal  pocket 5-7 mm

Ø  CAL 3-4 mm

Ø  Age 30 -50 years old;

Ø  Good general health

Ø  No periodontal treatment in the last 6 months

EXCLUSION CRITERIA

Ø  Antibiotic therapyin the last 3 months or during the study

Ø  Systemic diseases

Ø  Pregnancy orlactation.

Ø  Patients on drugtherapy

Ø  Smoker or any formof tobacco use

MATERIALS ANDMETHODS

CLINICALMEASUREMENTS

·      Probing pocketdepth (PPD) - measured from the gingival margin to the bottom of the pocket inall 6 sites of the involved teeth using periodontal probe

·      Clinicalattachment level (CAL) – recorded as probing depth +recession fixed at CEJ.Using periodontal probe.

·      Gingival index(Loe& Silness 1963)

·      Plaque index(Silness J & Loe H 1964).

PREPARATION OFROYAL JELLY IRRIGANT SOLUTION

¢ Royal jelly is commercially available in the form oftablets consisting 0.6 g.

¢ The tablets are crushed and dissolved in 60 mldistilled water to obtain a solution form of effective concentration. Finallyroyal jelly solution is obtained which will be used for irrigation purpose.They are delivered as in office irrigation using an irrigation device

¢ Irrigation time used is 10 -15 ml over 5 minutes (SaleetaMushtaq 2017)

METHODOLOGY

·      Following baselineclinical measurements, group A patients will receive royal jelly subgingivalirrigation ; group B will receive subgingival saline irrigation and group Cwill receive subgingival distilled water irrigation and

·      All irrigationagents will be delivered  using an irrigationdevice

·       Patients will be then recalled at 7thand14th day for  re-evaluationand clinical parameters are re-evaluated

Post-operative instructions- Oral hygiene instructions will be advised to brushtwice daily using modified bass technique

Followup – Patients recalled at 7thand 14th day from baseline and clinical measurements reevaluated

STATISTICAL ANALYSIS

Ø  ANOVA-to evaluatethe results at different time periods within the group and for intergroupcomparisons

POTENTIAL RISKS:

·      No potential risks involved in this procedure

·       Strict asepticprecautions will be followed