| 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
|
|
|
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
|
|
|
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. |