Edentulous MouthRMPNCT07246343
Impact of Retro-molar Pad Demarcation on Complete Denture Wearers' Satisfaction
A study testing carving of retromolar pad area (RMP) and no carving of the retromolar pad area (RMP) in people with Edentulous Mouth and Quality of Life, run by Samiha Sartawi at 1 site in Jordan.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Mouth, Quality of Life, Patient Satisfaction
- What is being tested?
- carving of retromolar pad area (RMP) and no carving of the retromolar pad area (RMP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteJordan
- Study dates
- 10 Feb 2022to 27 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- denture wearers
- any medical or soft tissue problems
- not signed the consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Retro-molar Pad Demarcation on Complete Denture Wearers' Satisfaction and Quality of Life: a Cross-over, Double-blind Clinical Trial.
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.
- Conditions
- Edentulous Mouth, Quality of Life, Patient Satisfaction, Complete Edentulism, Prosthesis Durability
- Being tested
- carving of retromolar pad area (RMP), no carving of the retromolar pad area (RMP)
- Keywords
- retromolar pad, lower denture, retention, patient satisfaction, quality of life
- Medical subject headings
- Mouth, Edentulous, Patient Satisfaction, Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carving of retromolar pad area (RMP)Procedure or surgery
carving of the retromolar pad area on the master cat while no carving is done in other studies
no carving of the retromolar pad area (RMP)Procedure or surgery
NO carving of the retromolar pad area (RMP area)
| Study group | Role | What they receive |
|---|---|---|
| edentolous patients | Experimental | patient satisfaction and quality of life Receives: 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 Receives: Procedure: carving of retromolar pad area (RMP); Procedure: no carving of the retromolar pad area (RMP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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..
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start10 Feb 2022
- Primary completion1 Feb 2024
- Study completion27 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Edentulous MouthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samiha Sartawi
- Sponsor type
- University, hospital or other
- Collaborators
- University of Jordan
- Responsible party
- Sponsor-investigator, Samiha Sartawi, University of Jordan
- Investigators
- SAMIHA SARTAWI, Principal investigator, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246343
- Sponsor's protocol ID
- 31/2019-2020
- Other IDs
- 31/2019-2020
- Acronym
- RMP
- Status last verified
- Nov 2025
- First submitted
- 30 Sep 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: confidentiality of patients
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 27437350Bhutta 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 at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Retro-molar Pad Demarcation on Complete Denture Wearers' Satisfaction and Quality of Life: a Cross-over, Double-blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT07246343
- Acronym / sponsor ID
- RMP / 31/2019-2020
- Conditions
- Edentulous Mouth, Quality of Life, Patient Satisfaction, Complete Edentulism, Prosthesis Durability
- Keywords
- retromolar pad, lower denture, retention, patient satisfaction, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Samiha SartawiUniversity, hospital or other
- Collaborators
- University of Jordan
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 27 Aug 2025 (actual)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| edentolous patients | Experimental | Procedure: carving of retromolar pad area (RMP), Procedure: no carving of the retromolar pad area (RMP)patient satisfaction and quality of life |
| Prosthodontist evaluation | Experimental | Procedure: carving of retromolar pad area (RMP), Procedure: no carving of the retromolar pad area (RMP)evaluation of mucosal changes and lower denture retention |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- denture wearers
- any medical or soft tissue problems
- not signed the consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carving of retromolar pad area (RMP)carving of the retromolar pad area on the master cat while no carving is done in other studies | Procedure or surgery | Prosthodontist evaluation, edentolous patients |
| no carving of the retromolar pad area (RMP)NO carving of the retromolar pad area (RMP area) | Procedure or surgery | Prosthodontist evaluation, edentolous patients |
Primary outcome
patient satisfaction
Time frame: Two months
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.
patient quality of life
Time frame: Two months
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.
1 secondary outcome
assessment of mucosal response and denture outcomes.
Time frame: Two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Background: PubMed 27437350Sharma 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.
- Background: PubMed 35852120Bhutta 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.
- Individual participant dataSharing planned: No. confidentiality of patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SAMIHA SARTAWI principal investigator
University of Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carving of retromolar pad area (RMP) and no carving of the retromolar pad area (RMP) in people with Edentulous Mouth and Quality of Life, run by Samiha Sartawi at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction (time frame: Two months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07246343, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.