| CTRI Number |
CTRI/2025/08/092660 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Evaluation of effect of surface treatment by Ceramic Glaze and Liner with HF on longitiviy Zirconia Frameworks in FDP |
|
Scientific Title of Study
|
A clinical trail to compare effect of surface treatment of zirconia framework using ceramic glaze versus ceramic liner in combination with with hydrofluoric acid on clinical outcome of fixed dental prosthesis layered with ceramics. |
| 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 Mithilesh Dhamande |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Prosthodontics and Crown and Bridge,Room no 202 Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
9890590584 |
| Fax |
|
| Email |
miths_d@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surekha Godbole |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Prosthodontics and Crown and Bridge,Room no 202 Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
9960084785 |
| Fax |
|
| Email |
drsurekhadubey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mithilesh Dhamande |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Prosthodontics and Crown and Bridge,Room no 202 Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
9890590584 |
| Fax |
|
| Email |
miths_d@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Wardha, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research, Wardha, India 442001 |
| Address |
Department of Prosthodontics and Crown and Bridge, Room no 202 Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Sawangi mehge, Wardha, Maharashtra |
| Type of Sponsor |
Private medical college |
|
|
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 Mithilesh Dhamande |
Sharad Pawar Dental College |
Department of Prosthodontics and Crown and Bridge, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Sawangi Mehge, Wardha, Maharashtra
Wardha
MAHARASHTRA |
9890590584
miths_d@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Partial edentulism requiring fixed dental prosthesis (mandibular molar region) |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Surface treatment of zirconia framework using hydrofluoric acid and ceramic glaze prior to ceramic veneering |
Zirconia frameworks will be surface-treated with 10% hydrofluoric acid followed by application of ceramic glaze before veneering with layered ceramic. The FDP will be cemented and evaluated using Modified USPHS criteria at baseline, 6 months, 1 year, and 2 years. |
| Comparator Agent |
Surface treatment of zirconia framework using hydrofluoric acid and ceramic liner prior to ceramic veneering |
Zirconia frameworks will be surface-treated with 10% hydrofluoric acid followed by application of ceramic liner before veneering with layered ceramic. The FDP will be cemented and evaluated using Modified USPHS criteria at baseline, 6 months, 1 year, and 2 years. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring single unit fixed dental prosthesis (FDP) in the mandibular molar region.
Patients opting for ceramic restorations.
Presence of natural teeth or fixed prosthesis in the opposing arch.
Good general health without systemic conditions that may affect outcomes.
Periodontally healthy tooth, either vital or endodontically treated.
Minimum clinical crown height of 5 mm on prospective abutment teeth.
No signs or symptoms of bruxism or clenching. |
|
| ExclusionCriteria |
| Details |
Patients not willing for oral hygiene maintenance.
Patients showing signs of occlusal wear in natural dentition |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical outcome of FDP evaluated using Modified USPHS criteria at 6 months, 1 year, and 2 years |
Clinical outcome of FDP evaluated using Modified USPHS criteria at 6 months, 1 year, and 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/08/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This randomized controlled clinical trial aims to evaluate and compare the clinical outcomes of zirconia-based fixed dental prostheses (FDPs) following two different surface treatment methods of the zirconia framework prior to ceramic layering. Group I will receive a surface treatment using hydrofluoric acid and ceramic glaze, while Group II will receive hydrofluoric acid and ceramic liner. A total of 60 patients requiring single-unit FDPs in the mandibular molar region will be enrolled. The clinical performance will be assessed using Modified United States Public Health Services (USPHS) criteria at baseline, 6 months, 1 year, and 2 years. The study seeks to determine which surface treatment method provides better longevity and clinical success in ceramic-layered zirconia FDPs. |