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CTRI Number  CTRI/2022/09/045497 [Registered on: 14/09/2022] Trial Registered Prospectively
Last Modified On: 07/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry
Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Subgingival irrigation with royal jelly solution 
Scientific Title of Study   EVALUATING THE EFFECT OF ROYAL JELLY SOLUTION AS A SUBGINGIVAL IRRIGANT-A RANDOMIZED CONTROLLED CLINICAL TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rudhra K 
Designation  PERIODONTOLOGY 
Affiliation  Vivekanandha dental college for women 
Address  Department of periodontology room no: 8 second floor, Elayampalayam, Tiruchengode-637205

Chennai
TAMIL NADU
637205
India 
Phone  8838991033  
Fax    
Email  rudhrakannan97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vennila K 
Designation  PERIODONTOLOGY 
Affiliation  Vivekanandha dental college for women 
Address  Department of periodontics, Room no:8,Second floor,Elyamaplayam,Tiruchengode-637205

Namakkal
TAMIL NADU
637205
India 
Phone  8838991033  
Fax    
Email  vennilamds@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rudhra K 
Designation  PERIODONTOLOGY 
Affiliation  Vivekanandha dental college for women 
Address  Department of periodontics, Room no:8,Second floor,Elyamaplayam,Tiruchengode-637205

Namakkal
TAMIL NADU
637205
India 
Phone  8838991033  
Fax    
Email  rudhrakannan97@gmail.com  
 
Source of Monetary or Material Support  
INSTITUTION-Vivekanandha dental college for women 
 
Primary Sponsor  
Name  RUDHRA 
Address  vivekanandha dental college for women, Tiruchengode  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
DrVennila K  vivekanandha dental college for women, Tiruchengode  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Rudhra  Vivekanandha dental college  Department of periodontics, Room no:8,Second floor,Elyamaplayam,Tiruchengode-637205
Namakkal
TAMIL NADU 		 8838991033

rudhrakannan97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  MEDICALLY HEALTHY INDIVIDUALS WITH CHRONIC PERIODNTITIS 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Distilled water   commercially available deionised water This is used as subgingival irrigant for 3-5 minutes after phase 1 therapy 
Intervention  Royal jelly solution  Royal jelly substance is commercially available in the form of tablets in the name of forever royal jelly containing 60 N tablets. Each tablet consists of 0.6 g of this substance. The solution form in effective concentration 60µg/ml is made by crushing one tablet and dissolving it in 60 ml distilled water to obtain a higher effective antimicrobial concentration as proved by invitro studies. This is used as subgingival irrigant for 3-5 minutes after phase 1 therapy 
Comparator Agent  saline solution  commercially available 0.9 % Nacl solution This is used as subgingival irrigant for 3-5 minutes after phase 1 therapy 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Atleast 10 teeth with two or more sites with periodontal pocket 5-7 mm deep; Clinical attachment loss upto 3-4 mm; Age 30 -50 years old; good general health and no periodontal treatment in the last 6 months.  
 
ExclusionCriteria 
Details  patients on antibiotic therapy within 3 months or during the study; systemic diseases; pregnancy or lactation; patients on drug therapy and smoker or any form of tobacco users. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
probing pocket depth  baseline and 45th day 
 
Secondary Outcome  
Outcome  TimePoints 
plaque index and gingival index   baseline and 45 days  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/09/2022 
Date of Study Completion (India) 07/10/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="20" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

AIM

To evaluate the clinical effect of subgingival irrigation with royal jelly in management of periodontal disease

OBJECTIVES

·       To evaluate the effect of subgingival irrigation with  royal jelly solution by means of clinical parameters

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

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

·       To compare the effects of subgingival irrigation for these three agents by means of clinical parameters

JUSTIFICATION FOR THE STUDY

The purpose of the study is mainly to evaluate clinical effect of new apitherapy product royal jelly solution as a subgingival irrigant in reducing clinical signs of periodontitis

 

MATERIALS & METHODS

This study includes 30 medically healthy individuals with chronic periodontitis undergoing periodontal therapy at the department of Periodontics in Vivekananda Dental College will be randomly selected. Written consent from the participants will be collected for the inclusion of this study

ü  Number of patients:30

CRITERIA FOR GROUPING

§  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 therapy in the last 3 months or during the study

Ø  Systemic diseases

Ø  Pregnancy or lactation.

Ø  Patients on drug therapy

Ø  Smoker or any form of tobacco use

MATERIALS AND METHODS

CLINICAL MEASUREMENTS

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

·       Clinical attachment 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 OF ROYAL JELLY IRRIGANT SOLUTION

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

¢ The tablets are crushed and dissolved in 60 ml distilled water to obtain a solution form of effective concentration. Finally royal 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 (Saleeta Mushtaq 2017)

METHODOLOGY

·       Following baseline clinical measurements, group A patients will receive royal jelly subgingival irrigation ; group B will receive subgingival saline irrigation and group C will receive subgingival distilled water irrigation and

·       All irrigation agents will be delivered  using an irrigation device

·        Patients will be then recalled at 7th and14th day for  re-evaluation and clinical parameters are re-evaluated

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

Follow up – Patients recalled at 7th and 14th day from baseline and clinical measurements reevaluated

STATISTICAL ANALYSIS

Ø  ANOVA-to evaluate the results at different time periods within the group and for intergroup comparisons

POTENTIAL RISKS:

·       No potential risks involved in this procedure

·        Strict aseptic precautions will be followed

 

 
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