Home » Trials » SLCTR/2026/029
Comparison of Oral Health–Related Quality of Life in Patients with Distal Extension Denture Bases Rehabilitated Using Cast and Flexible Partial Dentures: A six month follow up
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SLCTR Registration Number
SLCTR/2026/029
Date of Registration
The date of last modification
Oct 27, 2026
Scientific Title of Trial
Comparison of Oral Health–Related Quality of Life in Patients with Distal Extension Denture Bases Rehabilitated Using Cast and Flexible Partial Dentures: A six month follow up
Public Title of Trial
Comparison of Oral Health-Related Quality of Life in Patients with Mandibular Distal Extension Partial Edentulism Rehabilitated with Cast and Flexible Partial Dentures: A Randomized Controlled Trial
Disease or Health Condition(s) Studied
Oral Health.
Scientific Acronym
None
Public Acronym
Brief title
Comparison of Oral Health related Quality of life (OHRQoL) in Patients with Distal Extensions Bases Removable Partial Denture (RPD)
Universal Trial Number
U1111-1343-9359
Any other number(s) assigned to the trial and issuing authority
ANDC/RAC/2026/136
What is the research question being addressed?
Among adults with mandibular Kennedy Class I or II distal extension partial edentulism, is there a difference in the change in oral health-related quality of life from baseline to six months between patients rehabilitated with cast partial dentures and those rehabilitated with flexible partial dentures?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Device feasibility
Study Phase
Not Applicable
Intervention(s) planned
Study setting: The study will be conducted in the Department of Prosthodontics, Islam Dental College, Sialkot, and Azra Naheed Dental College, The Superior University, Lahore. Randomization: Eligible participants who provide informed consent will be randomly allocated in a 1:1 ratio to either the flexible removable partial denture group or the cast partial denture group. A computer-generated block randomization sequence will be used. Variable block sizes of 4 and 6 will be used to maintain balanced allocation while reducing predictability of the sequence. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes prepared according to the randomization sequence. The allocation envelope will be opened only after a participant has been enrolled and baseline assessment has been completed. Intervention group – Flexible removable partial denture: Participants allocated to the intervention group will receive a flexible removable partial denture fabricated using Vertex™ ThermoSens flexible resin. The denture will be fabricated, finished, fitted and adjusted according to the manufacturer's instructions and standard clinical prosthodontic procedures. Comparator group – Cast partial denture: Participants allocated to the comparator group will receive a cast removable partial denture fabricated with a cobalt-chromium framework (CERACAST C-C) and heat-activated acrylic denture base, following standard prosthodontic laboratory and clinical procedures. Insertion and follow-up: The assigned prosthesis will be inserted after completion of fabrication and clinical evaluation. Both groups will receive equivalent clinical instructions regarding insertion, removal, hygiene and maintenance. Necessary post-insertion adjustments will be provided according to clinical need. Outcome assessments will be performed using the same procedures and at the same predefined time points in both groups: baseline before prosthesis insertion, one month after insertion and six months after insertion.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Between-arm difference in mean change in total Oral Health–Related Quality of Life (OHIP-14) score. OHIP-14. Each item is scored 0–4, giving a total of 0–56; higher scores indicate poorer oral health-related quality of life. |
[ Baseline 6 months post insertion. ] |
Secondary outcome(s)
|
1.
Between-arm difference in mean change in total OHIP-14 |
[ 1 month post insertion ] |
|
2.
Between-arm difference in mean change in each OHIP-14 domain score (functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, handicap). Each domain is the sum of its two items (0–8). |
[ Baseline 1 month post insertion 6 months post insertion. ] |
Target number/sample size
20 subjects (10 in each arm)
Countries of recruitment
Pakistan
Anticipated start date
2026-11-01
Anticipated end date
2027-07-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
none
Regulatory approvals
Status
Approved
Date of Approval
2023-03-09
Approval number
ANDC/RAC/2023/30 and IDC/3/112
Details of Ethics Review Committee
| Name: | Azra Naheed Dental College |
| Institutional Address: | Main Campus: 31-Tipu, New Garden Town, Lahore. University Campus: 17-km Main Raiwind Road, Lahore. |
| Telephone: | 092-042-111-00-00-78, 092-042-35330361-3 |
| Email: |
Contact person for Scientific Queries/Principal Investigator
Dr.Naveed Inayat
Professor
Azra Naheed Dental College
Superior University, 17km Raiwind Rd, Kot Araian, Lahore, 54000
+924238104228
+923334436164
naveed.inayat@superior.edu.pk
Contact Person for Public Queries
Dr. Mahvish Wahad Khan
Assistant Professor
Avicenna Medical & Dental College
DHA Phase IX, Bedian Road, Lahore
+924237167562
+923004000343
mahvishwahad@avicennamch.edu.pk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
De-identified individual participant data underlying the results reported in the publication will be made available, including baseline demographic characteristics and individual OHIP-14 scores collected at baseline, one month and six months after prosthesis insertion. The study protocol and statistical analysis plan will also be made available where appropriate. Data will be shared with researchers who submit a methodologically sound research proposal for an approved scientific purpose, including secondary analyses and individual participant data meta-analysis. Requests should be directed to the Principal Investigator via the contact email provided in the trial record. Data requestors may be required to sign a data access agreement, and all shared data will be de-identified.
Study protocol available
Yes
Protocol version and date
Protocol URL
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
