| CTRI Number |
CTRI/2025/07/092083 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How Metal and Soft-Lined complete Dentures Affect Saliva pH in Toothless Patients Before and After Getting Dentures |
|
Scientific Title of Study
|
Influence of metal base complete denture and soft lined complete denture on the salivary pH in edentulous patients before and after prosthetic intervention |
| 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 Chitralekha Maravi |
| Designation |
Postgraduate Student |
| Affiliation |
Government Dental College Rajbandha Maidan path Raipur Chhattisgarh |
| Address |
Department of Prosthodontics, Room number 3 Government Dental College Rajbandha Maidan path Raipur Chhattisgarh
Department of Prosthodontics, Room number 3 Government Dental College Rajbandha Maidan path Raipur Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
9179820504 |
| Fax |
|
| Email |
maravichitra1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajendra Kumar Dubey |
| Designation |
Professor |
| Affiliation |
Government Dental College Rajbandha Maidan path Raipur Chhattisgarh |
| Address |
Department of Prosthodontics, Room number 3 Government Dental College Rajbandha Maidan path Raipur Chhattisgarh
Department of Prosthodontics, Room number 3 Government Dental College Rajbandha Maidan path Raipur Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
9229927756 |
| Fax |
|
| Email |
rkdubey2005@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chitralekha Maravi |
| Designation |
Postgraduate Student |
| Affiliation |
Government Dental College Rajbandha Maidan path Raipur Chhattisgarh |
| Address |
Department of Prosthodontics, Room number 3 Government Dental College Rajbandha Maidan path Raipur Chhattisgarh
Department of Prosthodontics, Room number 3 Government Dental College Rajbandha Maidan path Raipur Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
9179820504 |
| Fax |
|
| Email |
maravichitra1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College Rajbandha Maidan path Raipur Chhattisgarh India 492001 |
|
|
Primary Sponsor
|
| Name |
Dr Chitralekha Maravi |
| Address |
Department of Prosthodontics, Room number 3 Government Dental College Rajbandha Maidan path Raipur Chhattisgarh India 492001 |
| 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 |
| Dr Chitralekha Maravi |
Government Dental college Raipur |
Department of Oral and Maxillofacial Prosthodontics and Implantology room no 3 Government Dental College Rajbandha Maidan path Raipur Chhattisgarh
Raipur
CHHATTISGARH |
09179820504
maravichitra1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Human Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E089||Diabetes mellitus due to underlying condition without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1 Age including Middle and older age
2 Edentulous Patients
3 Systemically healthy subjects along patients with controlled diabetes and blood pressure
4 New or Past denture wearer but the denture is completely discontinued during new denture fabrication |
|
| ExclusionCriteria |
| Details |
1 Patients suffering from uncontrolled diabetes and blood pressure
2 Patients under medications such as antidepressant and neuroleptic drug
3 Patients suffering from any salivary gland disorder |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The research may provide an information regarding the influence of metal base complete denture and denture relined with soft liner on salivary pH before and after insertion of the prosthesis |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It will help the researcher to recognize the possibility of salivary pH changes due to certain prosthetic rehabilitation to such an extent which may affect the oral and general health of the individuals as well as the sanity of denture prosthesis itself |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 patients reporting to Department of Oral and Maxillofacial Prosthodontics and Implantology Government Dental College Raipur, are selected as per mentioned inclusion and exclusion criteria. The selected patients will be informed regarding his or her participation in this study and the treatment procedure is properly explained. A written informed consent forms will be obtained. Proforma will be used to collect data of the patients regarding age, gender, address, chief complaint, past dental history, medical history. Subjects will be selected randomly and divided into 2 groups. Group A will include those patients for whom metal base complete denture is planned. The patients, planned for fabrication of the complete denture with soft liner, will be included in group B. The complete denture with metal denture base and acrylic denture based lined with soft liner will be fabricated following all proper techniques and standard principles of prosthodontics. Unstimulated salivary pH will be estimated before delivery of denture at the day of denture insertion and after delivery of denture at the intervals of 1 month followed by 3 months using standardized spitting method. Patients will be instructed to refrain from eating, drinking, smoking 1hour prior to the saliva collection. Unstimulated saliva will be collected under standardized conditions between 9.00-11.00 AM. The Saliva will be collected into a container and salivary pH will be measured immediately after saliva collection using saliva pH meter. The values of salivary pH observed for subjects will be tabulated. The complete denture with metal denture base and acrylic denture based lined with soft liner will be fabricated following all proper techniques and standard principles of prosthodontics. Unstimulated salivary pH will be estimated before delivery of denture at the day of denture insertion and after delivery of denture at the intervals of 1 month followed by 3 months using standardized spitting method. Patients will be instructed to refrain from eating, drinking, smoking 1hour prior to the saliva collection. Unstimulated saliva will be collected under standardized conditions between 9.00-11.00 AM. The Saliva will be collected into a container and salivary pH will be measured immediately after saliva collection using saliva pH meter. The values of salivary pH observed for subjects will be tabulated. |