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CTRI Number  CTRI/2021/03/032132 [Registered on: 18/03/2021] Trial Registered Prospectively
Last Modified On: 17/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Correlation between thickness of gums and pH of fluid secreted by gums. 
Scientific Title of Study   Correlation between thickness of gingival biotype and pH of gingival crevicular fluid in healthy subjects 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shreedevi Pashupatimath 
Designation  Post Graduate Student Department of periodontics 
Affiliation  Sri Hasanamba Dental College and Hospital 
Address  Room no 5 Department of Periodontics Sri Hasanamba Dental college and hospital Vidyanagar Hassan KARNATAKA 573202 India
Room no 5 Department of Periodontics Sri Hasanamba Dental college and hospital Vidyanagar Hassan KARNATAKA 573202 India
Hassan
KARNATAKA
573202
India 
Phone  6364224430  
Fax    
Email  shreedentist6364@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Harsha MB 
Designation  Head of Department 
Affiliation  Sri Hasanamba Dental college and hospital 
Address  Room no 5 Department of Periodontics Sri Hasanamba Dental college and hospital Vidyanagar Hassan KARNATAKA 573202 India

Hassan
KARNATAKA
573202
India 
Phone  9845735007  
Fax    
Email  harshamb@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Harsha MB 
Designation  Head of Department 
Affiliation  Sri Hasanamba Dental college and hospital 
Address  Room no 5 Department of Periodontics Sri Hasanamba Dental college and hospital Vidyanagar Hassan KARNATAKA 573202 India

Hassan
KARNATAKA
573202
India 
Phone  9845735007  
Fax    
Email  harshamb@yahoo.com  
 
Source of Monetary or Material Support  
Sri Hasanamba Dental College and Hospital Vidyanagar Hassan 
 
Primary Sponsor  
Name  Sri Hasanamba Dental College 
Address  vidyanagar Hassan Karnataka 573202 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Shreedevi Pashupatimath  Sri Hasanamba dental college and hospital  Room no 5 Department of Periodontics vidhyanagar
Hassan
KARNATAKA 
6364224430

shreedentist6364@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Thick gingival biotype  A gingival thickness of ⩾2 mm is defined as thick biotype. Thick gingival tissue is associated with a broad zone of the keratinized tissue and flat gingival contour suggestive of thick bony architecture and also is more resistant to inflammation and trauma.  
Intervention  Thin gingival biotype  A gingival thickness of 1.5 mm is defined as thin biotype. Thin gingival tissue is associated with a thin band of the keratinized tissue, scalloped gingival contour suggestive of thin bony architecture and is more sensitive to inflammation and trauma.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Systemically healthy subjects
2. Subjects having all maxillary anterior teeth
3. Subject’s age 20-70 years 
 
ExclusionCriteria 
Details  1. Pregnant or lactating subjects
2. Subjects taking medication with any known effect on the periodontal soft tissues
3. Subjects with clinical signs of periodontal disease defined as having probing depth exceeding 3mm.
4. Subjects who are smokers.
5. Subjects with gingival hyperpigmentation.
6. Unable or not willing to comply with the study protocol. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Correlation between thickness of gingiva and pH of crevicular fluid  0th day 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation between thickness of gingiva and pH of crevicular fluid  0th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 2 
Date of First Enrollment (India)   20/03/2021 
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="0"
Months="1"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
Normally, there is a considerable intra-individual and inter-individual variation in both width and thickness of the facial gingiva, a fact that gives rise to the assumption that different gingival phenotypes might exist in any adult population. The bulky, slightly scalloped marginal gingiva with short and wide teeth on one hand and the thin, highly scalloped marginal gingiva with slender teeth on the other may serve to illustrate the existence of markedly different periodontal entities or so-called ‘‘gingival biotypes’’. The identification of the gingival biotype may be important in clinical practice since differences in gingival and osseous architecture have been shown to exhibit a significant impact on the outcome of restorative therapy. GCF plays a special part in maintaining the structure of junctional epithelium and the antimicrobial defense of periodontium. Understanding physical and chemical aspects of the gingival crevice microenvironment is essential for a comprehensive periodontal health evaluation. In this respect, gingival crevicular pH has been considered an indicator of periodontal health status and studied since 1954. It may play an important role in physiological and biochemical activities of the gingival crevice. In plaque-associated periodontal disease, crevicular pH is presumed to be influenced by changes in the microbial flora and proteinaceous metabolites, which produce inflammation in periodontal tissue. Many investigators have measured the crevicular pH and reported a relationship between pH and periodontal disease. This Randomized controlled clinical study aims to investigate the correlation between pH of gingival crevicular fluid and different types of gingival biotypes in healthy individuals.
 
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