| CTRI Number |
CTRI/2025/04/085543 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Evaluation of effect of Er YAG laser treatment on bonding
of long term soft liner with digitally fabricated Lower Complete Denture A clinical study |
|
Scientific Title of Study
|
Evaluation of effect of ErYAG laser treatment on bonding
of long term soft liner with 3D Printed Mandibular Complete
Dentures A randomized clinical cross over study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Khushali Shah |
| Designation |
Post Graduate student |
| Affiliation |
K M Shah Dental College and Hospital |
| Address |
Room no 9 Department of Prosthodontics, Crown and Bridge, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed To be University,Piparia
Vadodara
GUJARAT
391760
India |
| Phone |
9824140116 |
| Fax |
|
| Email |
khushalishah2505@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Piyush Javiya |
| Designation |
Reader |
| Affiliation |
K M Shah Dental College and Hospital |
| Address |
Room no 9 Department of Prosthodontics, Crown and Bridge, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed To be University,Piparia
Vadodara
GUJARAT
391760
India |
| Phone |
9978998492 |
| Fax |
|
| Email |
drpnjaviya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Piyush Javiya |
| Designation |
Reader |
| Affiliation |
K M Shah Dental College and Hospital |
| Address |
Room no 9 Department of Prosthodontics, Crown and Bridge, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed To be University,Piparia
Vadodara
GUJARAT
391760
India |
| Phone |
9978998492 |
| Fax |
|
| Email |
drpnjaviya@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Primary Sponsor
Modification(s)
|
| Name |
Dr Khushali Shah |
| Address |
Room no 9 Department of Prosthodontics, Crown and Bridge, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed To be University,Piparia
Vadodara
GUJARAT
391760
India |
| 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 Khushali Shah |
K M Shah Dental College and Hospital Sumandeep Vidhyapeeth Deemed to be University |
Room no 9 Department of Prosthodontics, Crown and Bridge, K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed To be University,Piparia
Vadodara
GUJARAT |
9824140116
khushalishah2505@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidhyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients who are completely edentulous requiring removable complete denture and first time denture wearers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3D Printed Mandibular Complete Dentures with Laser treatment |
3D Printed lower complete denture will be surface treated with Er:YAG Laser for 30 seconds prior to soft liner application. |
| Comparator Agent |
3D Printed Mandibular Complete Dentures without Laser treatment |
On 3d printed lower complete denture there will be no surface pre treatment with Er:YAG laser prior to soft liner application. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are completely edentulous requiring removable complete dentures.
2. First time denture wearers.
|
|
| ExclusionCriteria |
| Details |
1. Patients with implants or overdenture abutments in upper and lower arch.
2. Presence of any local and systemic disease that produce oral manifestations.
3. Patients with reduced salivary flow or having xerostomia.
4. Patients having any surgical or congenital maxillary or mandibular defects.
5. Patients who are not willing to sign the consent form,
6. Patients with reduced inter arch space.
7. Patients allergic to acrylic resin and silicone material.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bonding of long term soft liner with 3d Printed Mandibular Complete Denture with/without ErYAG laser treatment |
Baseline to 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="13"
Sample Size from India="13"
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)
|
05/05/2025 |
| 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="1"
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
|
This is a randomized clinical cross over study in which the participants will be provided with two set of lower 3d printed complete dentures .One denture will be surface treated with Er:YAG laser for 30 seconds which will be the intervention group . The second denture will be without any surface modification as a comparator agent . Soft liner will be applied on both the dentures . Bonding of soft liner with denture base will be evaluated by the secondary investigator at the time of denture insertion that is baseline data will be obtained using a five point visual scoring scale . Patient will be recalled after 1 month and the bonding will be evaluated again using five visual scoring scale and data will be obtained. The total participants will be 13. The data obtained at the baseline and 1 month will be compared at the end of the study. |