| CTRI Number |
CTRI/2023/10/058617 [Registered on: 13/10/2023] Trial Registered Prospectively |
| Last Modified On: |
07/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To compare complete dentures made using two different impression techniques for their fit, stability and function in resorbed mandibular ridges - A Clinical Study. |
|
Scientific Title of Study
|
Comparative evaluation of complete dentures fabricated using two different final impression techniques on retention, stability and masticatory efficiency in mandibular poor foundation patients - A Clinical 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 |
Dr. Riya Patel |
| Designation |
Postgraduate Student |
| Affiliation |
K M SHAH DENTAL COLLEGE AND HOSPITAL |
| Address |
K M Shah Dental College and Hospital. Room NO 9 Department of Prosthodontics,Crown and Bridge, Sumandeep Vidhyapeeh,AT & PO.Piparia, TA.Waghodia, District Vadodara.
K M Shah Dental College and Hospital. Room NO 9 Department of Prosthodontics,Crown and Bridge, Sumandeep Vidhyapeeh,AT & PO.Piparia, TA.Waghodia, District Vadodara.391760.
Vadodara
GUJARAT
391760
India |
| Phone |
9549670854 |
| Fax |
|
| Email |
riyapatel29153@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Piyush Javiya. |
| Designation |
Reader And Post Graduate Guide. |
| Affiliation |
K M SHAH DENTAL COLLEGE AND HOSPITAL |
| Address |
K M Shah Dental College and Hospital. Room NO 9 Department of Prosthodontics,Crown and Bridge, Sumandeep Vidhyapeeh,AT & PO.Piparia, TA.Waghodia, District Vadodara.391760.
K M Shah Dental College and Hospital. Room NO 9 Department of Prosthodontics,Crown and Bridge, Sumandeep Vidhyapeeh,AT & PO.Piparia, TA.Waghodia, District Vadodara.391760.
Vadodara
GUJARAT
391760
India |
| Phone |
9978998492 |
| Fax |
|
| Email |
drpnjaviya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Piyush Javiya. |
| Designation |
Reader And Post Graduate Guide. |
| Affiliation |
K M SHAH DENTAL COLLEGE AND HOSPITAL |
| Address |
K M Shah Dental College and Hospital. Room NO 9 Department of Prosthodontics,Crown and Bridge, Sumandeep Vidhyapeeh,AT & PO.Piparia, TA.Waghodia, District Vadodara.391760.
K M Shah Dental College and Hospital. Room NO 9 Department of Prosthodontics,Crown and Bridge, Sumandeep Vidhyapeeh,AT & PO.Piparia, TA.Waghodia, District Vadodara.391760.
Vadodara
GUJARAT
391760
India |
| Phone |
9978998492 |
| Fax |
|
| Email |
drpnjaviya@gmail.com |
|
|
Source of Monetary or Material Support
|
| K M Shah Dental College and Hospital. Room NO 9 Department of Prosthodontics,Crown and Bridge, Sumandeep Vidhyapeeh,AT & PO.Piparia, TA.Waghodia, District Vadodara.391760. |
|
|
Primary Sponsor
|
| Name |
Dr Riya Patel |
| Address |
NO.9 Department of Prosthodontics and Crown & Bridge.,
K M Shah Dental College
and Hospital, Sumandeep Vidyapeeth Deemed to Be University, Pipariya, Waghodia,
Vadodara:391760
GUJARAT |
| 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 Riya Patel |
K M SHAH DENTAL COLLEGE AND HOSPITAL |
K M Shah Dental College and Hospital. Room NO 9 Department of Prosthodontics,Crown and Bridge, Sumandeep Vidhyapeeh,AT & PO.Piparia, TA.Waghodia, District Vadodara.391760.
Vadodara
GUJARAT |
9549670854
riyapatel29153@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Admixed impression technique. |
In the admixed technique, secondary impression was made using McCord and Tyson’s Admixed technique for flat mandibular ridges. Impression compound and green tracing stick compound in the ratio of 3 : 7 parts by weight.this impression will be made on second appointment for every patient. |
| Intervention |
Cocktail impression technique. |
Cocktail impression technique -The technique described here utilizes the customized tray fabricated according to Dynamic impression technique described by Tryde et al. , impression material recommended by McCord and Tyson’s technique for atrophic mandibular ridge followed by functional impression as in closed mouth impression technique. So the word “Cocktail†refers to the combination of different impression techniques to obtain a definitive impression.This impression will be made on second appointment for every patient. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Completely edentulous participants with class v and class vi atrophic mandibular ridge reporting to OPD of the department of prosthodontics, K. M shah dental college and hospital.
2. Systemically healthy patient.
3. Patients with history of no habits such as tobacco chewing, ciggarate smoking, aracanut chewing habits.
4. Patients who are willing to participate in the study and sign the consent form.
|
|
| ExclusionCriteria |
| Details |
1. Patients having any surgical or congenital mandibular defects.
2. Patients with poor neuromuscular control.
3. Patients who are immune compromised.
|
|
|
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 |
| Retention and Stability. |
At Baseline and 4 weeks after denture insertion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Masticatory Efficiency. |
Masticatory Efficiency Evaluated
4 Weeks After Denture Insertion. |
|
|
Target Sample Size
|
Total Sample Size="29"
Sample Size from India="29"
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 3 |
|
Date of First Enrollment (India)
|
01/11/2023 |
| 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="1"
Months="6"
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
|
In this clinical study we will be comparatively evaluating complete dentures fabricated using two different final impression techniques i.e admixed impression technique and cocktail impression technique following selective pressure and functional impression techniques respectively in mandibular poor foundation patients on retention, stability and masticatory efficiency.In the admixed technique, secondary impression was made using McCord and Tyson’s admixed technique for flat mandibular ridges. Impression compound and green tracing stick compound in the ratio of 3 : 7 parts by weight.9 Cocktail impression technique -The technique described here utilizes the 9 customized tray fabricated according to Dynamic impression technique described by Tryde et al. , impression material recommended by McCord and Tyson’s technique for atrophic mandibular ridge followed by functional impression as in closed mouth impression technique. So the word “Cocktail†refers to the combination of different impression techniques to obtain a definitive impression.the scoring of the stability and retention(dynamometer test) will be given as per CU modified kapur’s scale.The masticatory efficiency of the patients will be measured using colour changing chewing gum(Xylitol, Lotte). Patient will be asked to chew the chewing gum and it will be evaluated using spectrophotometry. |