NCT07246343

Brief Summary

the retromolar pad is a critical anatomical landmark in the lower edentulous arch marking the posterior end of any removable prosthesis. The significance of using this area to aid the retention of the lower denture is evaluated in this clinical study especially that the lower denture is always inferior in retention compared to the upper denture as a result of reduced denture bearing area.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 30, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

September 30, 2025

Last Update Submit

November 22, 2025

Conditions

Edentulous MouthQuality of LifePatient SatisfactionComplete EdentulismProsthesis Durability

Keywords

retromolar padlower dentureretentionpatient satisfactionquality of life

Outcome Measures

Primary Outcomes (2)

  • patient satisfaction

    Patient satisfaction after carved and non carved areas in lower denture. After each period, a blinded dentist asked participants to rate their satisfaction on a 100-mm visual analogue scale regarding eating, taste perception, speaking, and phonetics.

    Two months

  • patient quality of life

    The quality of life of participants after carved and non carved areas in lower denture was assessed. Participants were asked to fill the 20-item oral health impact profile for edentulous patients (OHIP-EDENT) before and after treatment with each experimental lower denture.

    Two months

Secondary Outcomes (1)

  • assessment of mucosal response and denture outcomes.

    Two months

Study Arms (2)

edentolous patients

EXPERIMENTAL

patient satisfaction and quality of life

Procedure: carving of retromolar pad area (RMP)Procedure: no carving of the retromolar pad area (RMP)

Prosthodontist evaluation

EXPERIMENTAL

evaluation of mucosal changes and lower denture retention

Procedure: carving of retromolar pad area (RMP)Procedure: no carving of the retromolar pad area (RMP)

Interventions

carving of retromolar pad area (RMP)PROCEDURE

carving of the retromolar pad area on the master cat while no carving is done in other studies

Prosthodontist evaluationedentolous patients
no carving of the retromolar pad area (RMP)PROCEDURE

NO carving of the retromolar pad area (RMP area)

Prosthodontist evaluationedentolous patients

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recent extraction with the last tooth extracted for at least three months ago
  • No previous denture experience (first time complete denture wearers) in both maxilla and mandible
  • Ridge classification: Atwood's class III in both maxilla and mandible
  • No relevant medical conditions or oral pathologies including lesions or ulcers, xerostomia, or tongue tie that could affect the treatment or compliance with treatment
  • Both genders aged 40-80 years
  • Participants who signed the consent form

You may not qualify if:

  • denture wearers
  • any medical or soft tissue problems
  • not signed the consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jordan

Amman, +962, Jordan

Location

Related Publications (2)

  • Sharma A, Deep A, Siwach A, Singh M, Bhargava A, Siwach R. Assessment and Evaluation of Anatomic Variations of Retromolar Pad: A Cross Sectional Study. J Clin Diagn Res. 2016 May;10(5):ZC143-5. doi: 10.7860/JCDR/2016/19551.7880. Epub 2016 May 1.

    PMID: 27437350BACKGROUND

  • Bhutta HE, Moharamzadeh K, Martin R, Martin N. Patient Satisfaction with Upper and Lower Complete Dentures: A Service Evaluation Report. Eur J Prosthodont Restor Dent. 2023 Feb 28;31(1):59-71. doi: 10.1922/EJPRD_2416Bhutta13.

    PMID: 35852120BACKGROUND

MeSH Terms

Conditions

Mouth, EdentulousPatient SatisfactionProsthesis Failure

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth DiseasesTreatment Adherence and ComplianceHealth BehaviorBehaviorPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • SAMIHA SARTAWI

    University of Jordan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 30, 2025

First Posted

November 24, 2025

Study Start

February 10, 2022

Primary Completion

February 1, 2024

Study Completion

August 27, 2025

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

confidentiality of patients

Locations

JO(1)