| CTRI Number |
CTRI/2023/10/058916 [Registered on: 19/10/2023] Trial Registered Prospectively |
| Last Modified On: |
14/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to correlate the thickness of gum and jaw bone type with the thickness of nose air space lining |
|
Scientific Title of Study
|
Reliability of Periodontal Phenotype as an Indicator in the Assessment of Schneiderian Membrane Thickness-A Correlation Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Veeramallu Nageswari |
| Designation |
postgraduate student |
| Affiliation |
Vishnu Dental College |
| Address |
Room no-7,Block 2,Department of Periodontics and Implantology, Vishnu Dental College, Vishnupur, Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
6300558030 |
| Fax |
|
| Email |
veeramallunageswari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gautami S Penmetsa |
| Designation |
Head Of the Department |
| Affiliation |
Vishnu Dental College |
| Address |
Room no-7,Block 2,Department of Periodontics and Implantology, Vishnu Dental College, Vishnupur, Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9951011618 |
| Fax |
|
| Email |
gautamipenmetsa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gautami S Penmetsa |
| Designation |
Head Of the Department |
| Affiliation |
Vishnu Dental College |
| Address |
Room no-7,Block 2,Department of Periodontics and Implantology, Vishnu Dental College, Vishnupur, Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9951011618 |
| Fax |
|
| Email |
gautamipenmetsa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College,
Vishnupur, Bhimavaram,West godavari district,Andhra pradesh-534202 |
|
|
Primary Sponsor
|
| Name |
Veeramallu Nageswari |
| Address |
Room no-7,Block 2,Department of Periodontics and Implantology, Vishnu Dental College, Vishnupur, Bhimavaram. |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Veeramallu Nageswari |
Vishnu Dental College |
Room no-7,Block 2,Department of Periodontics and Implantology, Vishnu Dental college,Vishnupur,Bhimavaram,
West Godavari, Andhrapradesh.
West Godavari
ANDHRA PRADESH |
6300558030
veeramallunageswari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vishnu Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers with the presence of maxillary first or second molar tooth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with presence of first or second maxillary molars
2.Probing depth of 3 mm or less,
3.Firm gingiva and without traumatic occlusion
|
|
| ExclusionCriteria |
| Details |
1.Untreated periodontal disease,
2.Previous periodontal surgery and previous sinus surgery,
3.History of previous orthodontic treatment,
4.Consumption of drugs with gingival enlargement side effect,
5.Pregnancy,
6.Tobacco smoking,
7.Over erupted mandibular molars, and
8.Severe bone loss in the maxillary molar region
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical parameters: 1.Gingival thickness(GT).
2.width of keratinized tissue(WKT).
Radiological parameters:
3.Schneiderian membrane thickness in maxillary posteriors.
4.Thickness of the labial plate of the alveolar crest.(TLPAC).
|
All parameters are measured at baseline.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
25/10/2023 |
| 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="6"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
The main aim of the study is to evaluate the correlation between periodontal phenotype and Schneiderian membrane thickness in relation to maxillary posteriors. A total of 36 patients fulfilling the inclusion criteria will be selected from outpatient department of Periodontics and Implantology, Vishnu Dental college, Bhimavaram. Clinical parameters: 1. Gingival thickness(GT) 2. width of keratinized tissue(WKT).
Radiological parameters: 3.Schneiderian membrane thickness in maxillary posteriors. 4.Thickness of the labial plate of the alveolar crest (TLPAC) will be assessed. Correlation between the periodontal phenotype and Schneiderian membrane thickness in relation to maxillary posteriors will be evaluated. |