| CTRI Number |
CTRI/2025/11/098190 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of accelerated and routine complete dentures on quality of life of totally edentulous individuals |
|
Scientific Title of Study
|
Comparison of accelerated and simplified dentures with conventional dentures in patients with total edentulism: Randomized trial to assess denture quality, quality of life, and nutrition |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Nanda |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 205, Division of Prosthodontics, Centre for Dental Education and Research
Room No. 215, Division of Prosthodontics, Centre for Dental Education and Research
South
DELHI
110029
India |
| Phone |
09871167927 |
| Fax |
|
| Email |
aditinanda@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditi Nanda |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 205, Division of Prosthodontics, Centre for Dental Education and Research
Room No. 215, Division of Prosthodontics, Centre for Dental Education and Research
DELHI
110029
India |
| Phone |
09871167927 |
| Fax |
|
| Email |
aditinanda@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Nanda |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 205, Division of Prosthodontics, Centre for Dental Education and Research
Room No. 215, Division of Prosthodontics, Centre for Dental Education and Research
DELHI
110029
India |
| Phone |
09871167927 |
| Fax |
|
| Email |
aditinanda@yahoo.com |
|
|
Source of Monetary or Material Support
|
| ICMR small grant 2025-IIRPSG-20250100536
Indian council of Medical research, Ansari Nagar, New Delhi, India, 110029 |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V Ramalingaswami Bhawan
Ansari Nagar, Post box 4911, New Delhi, India, 110029 |
| Type of Sponsor |
Research institution |
|
|
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 Aditi Nanda |
Division of Prosthdontics, AIIMS NEW Delhi |
Room No. 205, Division of Prosthodontics, Centre for Dental Education and Research
New Delhi
DELHI |
09871167927
aditinanda@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Completely edentulous |
| Patients |
(1) ICD-10 Condition: K081||Complete loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Accelerated, simplified complete denture |
1 appointment for impression (compound and zinc oxide eugenol)
Dose is not applicable in this case as this is an impression making procedure as quantity of impression is as per jaw size
Frequency is once, as impression will be made only once
Total duration to make a denture is 4 appointments / 4 days |
| Comparator Agent |
Conventional Complete denture (CCD) |
2 appointment based complete denture fabrication process as is routinely followed.
1 appointment for impression (compound and zinc oxide eugenol)
Dose is not applicable in this case as this is an impression making procedure as quantity of impression is as per jaw size
Frequency is twice, as impression will be made 2 times.
Total duration to make a denture is 5 appointments / 5 days |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
The participants will be completely edentulous individuals between the age of 55 to 80 years. Period of edentulism will be not less than 6 months. Participants enrolled will be 1st time denture wearers. Participants providing written informed consent will be included in the study.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria will consist of presence of temporomandibular disorders, insufficient mouth opening, presence of systemic illnesses compromising nutritional status such as liver disorders, renal disorders, cancer, endocrinal disorders, gastrointestinal disorders, metabolic disorders, and presence of psychiatric disorders.
|
|
|
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 |
| Geriatric Oral Health Assessment Index (Hindi) |
1 week after insertion , 12 months after insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nutritional Risk Index (NRI) |
At denture placement and 12 months after denture placement |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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="3"
Months="0"
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 study aims to address this gap by evaluating an accelerated, simplified complete denture (ASCD) protocol. The aim is to reduce the overall time of rehabilitation. The economical use of materials shall help to curtail the cost of treatment as well. These strategies will attempt to maximize quality quantity by recommending an efficient and less complex procedure particularly when on a constraint budget.The reduction in number of appointments is also accompanied by economical use of materials and use of materials that enable to use the technique in a wide spectrum of clinical conditions (Prosthodontic diagnostic index I to IV).The study shall help to determine whether the alternate ASCD technique helps to generate clinically acceptable dentures (denture quality), meets the oral health related quality of life (GOHAI-H), and attain a satisfactory nutritional status (NRI)in accordance with the CCD therapy. 80 participants will be enrolled as per inclusion and exclusion criteria. Study Area : Hospital Division of Prosthodontics, Centre for Dental Education and Research, AIIMS New Delhi and Lab Medicine, AIIMS New DelhiThe participants will be completely edentulous individuals between the age of 55 to 80 years. Period of edentulism will be not less than 6 months. Participants enrolled will be 1st time denture wearers. Participants providing written informed consent will be included in the study. Exclusion criteria will consist of presence of temporomandibular disorders, insufficient mouth opening, presence of systemic illnesses compromising nutritional status such as liver disorders, renal disorders, cancer, endocrinal disorders, gastrointestinal disorders, metabolic disorders, and presence of psychiatric disorders. Completely edentulous participants (as per inclusion and exclusion criteria) who will be treated by conventional complete denture fabrication technique will be included as controls. Study design is Concurrent parallel arm Duration of follow up is 12months. At time of denture placement and 12 months after placement the following investigations will be done: GOHAI (H), Nutritional risk Index (albumin, height, and weight will be required), and denture quality by using Woelfel’s index. |