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CTRI Number  CTRI/2025/10/096409 [Registered on: 23/10/2025] Trial Registered Prospectively
Last Modified On: 23/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the effect of Vitamin-C and Dextrose in triangular black gaps between teeth gums 
Scientific Title of Study   Comparative Evaluation of Vitamin-C and Dextrose in Papilla augmentation : A randomized controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tejaswi Kodem 
Designation  Assistant Professor 
Affiliation  Gitam Dental College 
Address  Department Of Periodontics,
Department Of Periodontics, Gitam Dental College And Hospital, Rushikonda.
Visakhapatnam
ANDHRA PRADESH
530045
India 
Phone  09381154793  
Fax    
Email  tkodem@gitam.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Tejaswi Kodem 
Designation  Assistant Professor 
Affiliation  Gitam Dental College 
Address  Department Of Periodontics,
Department Of Periodontics, Gitam Dental College And Hospital, Rushikonda.
Visakhapatnam
ANDHRA PRADESH
530045
India 
Phone  09381154793  
Fax    
Email  tkodem@gitam.edu  
 
Details of Contact Person
Public Query  
Name  Dr Tejaswi Kodem 
Designation  Assistant Professor 
Affiliation  Gitam Dental College 
Address  Department Of Periodontics,
Department Of Periodontics, Gitam Dental College And Hospital, Rushikonda.
Visakhapatnam
ANDHRA PRADESH
530045
India 
Phone  09381154793  
Fax    
Email  tkodem@gitam.edu  
 
Source of Monetary or Material Support  
Gitam Dental College and Hospital, Rushikonda, Andhra Pradesh Visakhapatnam -530045 India 
 
Primary Sponsor  
Name  tejaswi kodem 
Address  Department Of Periodontics, Gitam Dental College ,And Hospital, Rushikonda Visakhapatnam- 530045 India Rushikonda. Visakhapatnam 530045 India 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrTejaswi Kodem  Gitam Dental College   Department Of Periodontics, Gitam Dental College And Hospital, Rushikonda.
Visakhapatnam
ANDHRA PRADESH 		 09381154793

tkodem@gitam.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE (IEC) CERTIFICATE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dextrose  5 % dextrose 1ml , 3 times in 3 weeks at 1st month ,3 rd month and 6th month. 
Comparator Agent  vit c  vitc 1ml , 3 times in 3 weeks at 1st month ,3 rd month and 6th month. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Male and female patients between the age groups of 18–55 years with papillary recession in the anterior teeth with intact contact point according to (Nordland and Tarnow class 1 and 2)
 
 
ExclusionCriteria 
Details  Pregnant and lactating women.
Patients with deleterious habits.
systemic unhealthy patients.
patients receiving orthodontic treatment
patients with implants, and endodontically treated teeth.
patients with allergy/systemic disease/treatment that contraindicate or compromise results of surgical procedure
Patients with caries, restoration, or crowns present in the adjacent teeth
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare and evaluate vit c and dextrose as excellent non-surgical methods in regeneration of IDP loss in systemically healthy patients.
 		 1st month, 3rd month, 6th month 
 
Secondary Outcome  
Outcome  TimePoints 
to fill black triangle  1st month ,3 rd month & 6th month. 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  will be provided on request over mail

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

To compare and evaluate vit c and dextrose as excellent non-surgical methods in regeneration of inter dental papilla loss in systemically healthy patients.


 
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