| CTRI Number |
CTRI/2024/12/077654 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate salivary pH after placement of implant-supported prosthesis fabricated using ti-based abutments and dmls abutments. |
|
Scientific Title of Study
|
Evaluation of salivary pH after placement of implant-supported prosthesis fabricated using Ti-based abutments and DMLS abutments. |
| 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 Shubham Sethi |
| Designation |
Post graduate student |
| Affiliation |
GDC Raipur |
| Address |
Government dental college
Rajbandha, Maidan Path, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
8770691417 |
| Fax |
|
| Email |
shubham.sethi28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepesh kumar Gupta |
| Designation |
PROF & HOD |
| Affiliation |
GDC Raipur |
| Address |
Government dental college
Rajbandha, Maidan Path, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
8966910000 |
| Fax |
|
| Email |
dr_deepesh25@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubham Sethi |
| Designation |
Post graduate student |
| Affiliation |
GDC Raipur |
| Address |
Government dental college
Rajbandha, Maidan Path, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
8770691417 |
| Fax |
|
| Email |
shubham.sethi28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral & Maxillofacial Prosthodontics & Implantology
Government Dental College, Rajbandha Maidan Path Raipur(
C.G) India 492001 |
|
|
Primary Sponsor
|
| Name |
Dr Shubham Sethi |
| Address |
Room no. 115
Boys hostel
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 Shubham Sethi |
Government Dental College, Raipur |
Room no. 03
Department of oral & Maxillofacial Prosthodontics & Implantology
Rajbandha, Maidan Path, Raipur, Chhattisgarh
Raipur
CHHATTISGARH |
08770691417
shubham.sethi28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College Raipur(C.G) Institutional ethics Committee(Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Evaluate the salivary pH after placement of implant supported prosthesis fabricated using two different types of abutments – Ti based and DMLS based. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with age ≥18 years.
2.Patient did not suffer from any disease which affects the pH of saliva.
3.Patient had not worn any fixed prosthesis in past and present.
4.Patient did not suffer from any salivary gland disorder.
5.Patient did not suffer from xerostomia or sialorrhea.
6.Patient did not worn any DMLS and Ti based implant supported prosthesis in past and present.
|
|
| ExclusionCriteria |
| Details |
1.Patient suffering from salivary gland disorder.
2.Patient undergoing radiotherapy or chemotherapy.
3.Patient suffering from denture stomatitis, squamous cell carcinoma, immunologic mucosal lesions.
4.Patients with uncontrolled systemic disorders are excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study helps to determine the changes in salivary pH after placement of implant-supported prostheses fabricated using Ti-based abutments and DMLS abutments. |
At baseline and 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Type of prosthesis material suitable in patient with reduced pH.
2. Management of patient with decreased pH with substitutes/supplements that counter the change in pH of saliva.
|
0,1 month |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/12/2024 |
| Date of Study Completion (India) |
16/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
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
|
Hypothesis : There is no variation in salivary pH after placement of Ti based and DMLS based prosthesis.
Aim: To evaluate the salivary pH after placement of implant supported prosthesis fabricated using two different types of abutments – Ti based and DMLS based. Objectives: 1. To evaluate the change in pH of saliva before and after placement of implant supported prosthesis fabricated using Ti based abutments. 2. To evaluate the change in pH of saliva before and after placement of implant supported prosthesis fabricated using DMLS abutments. 3. To Compare the change in salivary pH in case of Ti based and DMLS prosthesis.
|