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CompletedNCT07246343RMPUpdated Nov 28, 2025

Impact of Retro-molar Pad Demarcation on Complete Denture Wearers' Satisfaction

An interventional study of carving of retromolar pad area (RMP) and no carving of the retromolar pad area (RMP) in Edentulous Mouth, Quality of Life and Patient Satisfaction, sponsored by Samiha Sartawi. Completed at 1 site in Jordan. Open to participants aged 40 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-28.

Sponsored by Samiha Sartawi · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 7 months after the study started (first participant enrolled Feb 2022, registered Sep 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

The retromolar pad is a key intraoral anatomical landmark in removable prosthodontics. It comprises of non-keratinized loose alveolar tissue covering glandular tissues and muscle fibers. The denture base should extend to cover the retromolar pad. There are variations in the anatomical shape of the retromolar pad, however, no reports in the literature to record that area on the cast and to measure its effect on the retention of the lower denture.

The retromolar pad is a key intraoral anatomical landmark in removable prosthodontics. The denture base should cover the retromolar pad not only to provide proper peripheral seal but also for stability of the denture by adding another plane to resist movements of the base. Furthermore, it remains a stable landmark even in advanced ridge resorption. It is also considered a crucial landmark to determine the occlusal plane where the later terminates posteriorly in the middle of the upper third of the retromolar pad. The mandibular first molar is usually found at the level corresponding to the anterior two thirds of the retromolar pad area. The pad comprises of non-keratinized loose alveolar tissue covering the glandular tissues, fibers of buccinator muscle, fibers of superior constrictor muscle, fibers of ptergomandibular raphe and the terminal part of the tendon of temporalis muscle. After the molars are lost the bone and surrounding soft tissues remodels, resorbs and blends with retromolar pad. The mylohyoid muscles and the buccinator muscles affixed to nearby bony areas are some of the barriers to the chronic but limited bone resorption of the retromalr pad, following tooth loss, time of edentulism, systemic factors, and denture wear.

There are variations in the anatomical shape (pear, triangular and circular) and size of retromolar pad area both in the same patient and in different patients. It was reported that the denture posterior border should be defined at least more posteriorly than in the 2/3 of the retromolar pad (positioned about 7mm distal to the anterior margin of the retromolar pad) and preferably as much as possible to be extended to the distal end dome of the retromolar pad (about 15mm from the anterior margin of the retromolar pad).

The lower denture is usually less retentive than the upper denture due to the reducced surface area covered. The retromolar pad area defines the posterior end of the denture and helps in the retention and stability of the lower denture, however no reports in the literature to record that area on the cast and to measure its effect on retention. Therefore, this clinical study aims to evaluate the effect of carving the retromolar pad area on the retention of the lower denture.

Therefore this clinical study aims to evaluate the effect of carving the retromolar pad area on the retention of lower denture. 50 edentulous patients with no previous denture history will be recruited. Complete dentures will be constructed for each patient with two sets of mandibular dentures by one prosthodontist. One conventional lower denture and one denture with added rertomolar pad whereby one of the dentures will be delivered and after one month the second denture is delivered. Both dentures will be assessed one month after insertion using validated questionnaires. Clinical assessment of the dentures will be performed by two blind prosthodontists on a visual analogue scale. Data will be analyzed using SPSS software.

02

Conditions studied

  • Edentulous Mouth
  • Quality of Life
  • Patient Satisfaction
  • Complete Edentulism
  • Prosthesis Durability

Keywords

  • retromolar pad
  • lower denture
  • retention
  • patient satisfaction
  • quality of life
03

In context

Mouth, Edentulous

124 studies on the registry are indexed under Mouth, Edentulous; 17 are open to participants now.

This study's enrollment of 50 is above the median of 36 across 93 interventional studies indexed under Mouth, Edentulous.

Browse Mouth, Edentulous studies →

Lead sponsor

This is the only study on the registry with Samiha Sartawi as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • denture wearers
  • any medical or soft tissue problems
  • not signed the consent form
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    edentolous patients

    patient satisfaction and quality of life

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

  • Experimental
    Prosthodontist evaluation

    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

  • Procedurecarving of retromolar pad area (RMP)

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

  • Procedureno carving of the retromolar pad area (RMP)

    NO carving of the retromolar pad area (RMP area)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Two months

  2. 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.

    Time frame: Two months

Secondary outcomes

  1. assessment of mucosal response and denture outcomes.

    differences in mucosal reaction after using carved denture (CLD) and non carved denture (NCLD) whether presence or absence of redness, erosion, keratosis, ulceration, and denture fissuratum. Two blinded prosthodontists evaluated the CLD and NCLD regarding mucosal changes, and also rated the retention, support, and stability of upper and lower dentures (CLD and NCLD) on a100-mm VAS scale..

    Time frame: Two months

07

Study locations

1 site
  • University of Jordan
    Amman, +962, Jordan
08

References and documents

Publications

  • 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. PubMed 27437350 ↗
  • 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. PubMed 35852120 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — confidentiality of patients

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07246343
Lead sponsor
Samiha Sartawi
Responsible party
Samiha Sartawi (Principal investigator, University of Jordan) — Sponsor-investigator
First posted
Nov 24, 2025
Start date
Feb 10, 2022
Primary completion
Feb 1, 2024
Completion
Aug 27, 2025
Last update
Nov 28, 2025

Study contacts

SAMIHA SARTAWI
principal investigator · University of Jordan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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