The Impact of Rugae Reproduction on Complete Dentures Patients' Satisfaction
NCT ID: NCT03879083
Last Updated: 2020-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
44 participants
INTERVENTIONAL
2019-05-01
2020-02-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact of Different Palatal Contour Designs on Patients' Satisfaction and Oral Health Related Quality of Life
NCT04985747
Efficacy of Fascia Lata Allograft and Platelet Rich Fibrin on the Periodontal Phenotype Around Dental Implant
NCT06219473
Digital Versus Conventional Impression in Edentulous Patients With Flabby Ridge.
NCT07108322
Palatal Wound Healing Evaluation After Application of Platelet Rich Fibrin Versus 0.2% Hyaluronic Acid Dressings
NCT04390100
Effectiveness of iPRF Injections in Temporomandibular Joints Degeneration Management
NCT05214924
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The palatal rugae, refer to asymmetrical and irregular elevations of the mucosa located in the anterior third of the palate, on each side of the median palatal raphe and behind the incisive papilla. In addition to enhancing phonetics, the precise reproduction of the rugae in the complete dentures has been suggested to enhance mastication, deglutition and better taste perception. However, these suggestions were based on empirical evidence.
Many studies have described methods for replicating the patients rague on complete dentures, however there are no clinical study to ascertain or negate the impact of this procedure. Therefore, the aim of this randomized crossover clinical trial was to compare patients' reported satisfaction with their complete dentures and oral health related quality of life, when provided with a denture with a reproduction of their rugae on the anterior palatal area as opposed to a polished palatal surface. The null hypothesis was that there would be no difference in patients' reported satisfaction rate using visual analogue scale (VAS) and Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT) Questionnaire response between the two types of palatal contours after using each type for one month post-delivery.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
After insertion, all participants will be followed up for a minimum of 1 week to correct any issues with the dentures and eliminate patient complaints.
All patients will be recalled at 2 month after insertion to answer questions using the VAS and to fill out the Oral Health Impact Profile-20 EDENT (OHIP-EDENT), and receive the other type of palatal contour.
After the second periodthe same process will be repeated.
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
With reproduction of palatal rugae
Participants will receive maxillary complete dentures with a reproduction of the patients's own palatal rugae to the palatal surface.
The removal of the palatal rugae from the complete denture surface
The removal of the palatal rugae from the complete maxillary denture palatal surface to become a smooth surface
Without reproduction of palatal rugae (smooth surface)
Participants will receive maxillary complete dentures with smooth palatal surfaces without a reproduction of the patients's own palatal rugae to the palatal surface.
Addition of palatal rugae to the complete denture surface
The addition and reproduction of the patient's own palatal rugae to the complete maxillary denture palatal surface.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Addition of palatal rugae to the complete denture surface
The addition and reproduction of the patient's own palatal rugae to the complete maxillary denture palatal surface.
The removal of the palatal rugae from the complete denture surface
The removal of the palatal rugae from the complete maxillary denture palatal surface to become a smooth surface
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients aged between 45 and 80 years old.
* Patients had been completely edentulous for at least 3 months
* Patients without severe underlying medical conditions, neuromascular dysfunction, auditory problems, mental conditions, oral pathology, xerostomia, or tied tongue condition.
* Patients who approved and consented to participation.
45 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Jordan
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Motasum Abu-Awwad
Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Jordan Hospital
Amman, , Jordan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10/2019/27400
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.