To check fit of upper denture and its effect on palatal tissue using two methods to establish seal in completely edentulous patients
- Conditions
- Disorder of gingiva and edentulousalveolar ridge, unspecified,
- Registration Number
- CTRI/2021/04/032679
- Lead Sponsor
- Dr Riddhi Lalan
- Brief Summary
Completedenture prosthodontic treatment is an integral aspect of the dentistry as thequality of life is compromised due to complete tooth loss. Patient’s desiresare considered as prime element in fabrication of prosthesis for giving asuccessful treatment. The patient’s satisfaction or perception has always beena key objective in any prosthodontic treatment.
Thekey in fabricating a good set of complete denture greatly depends on achieving objectivesof preservation, stability, support, retention, aesthetics and comfort. Retention,thus, plays a very important role in complete denture.
Establishingproper posterior palatal seal commands a definite clinical procedural protocolif one is to create an optimally retentive complete maxillary prosthesis. In thisstudy two methods of establishing the PPS will be followed. One, theconventional method wherein the PPS will be recorded using low fusing greenstick compound and other wherein a novel device named “compograph†aidedtechnique shall be used where the the compressibility of tissue is recorded todefine its resiliency. Being an indigenously developed instrument andtechnique, there exists a need to use the instrument to establish the PPS sealand compare both retention and clinical soft tissue changes with theconventional semi functional method. Hence a need to conduct the study was feltnecessary with following objectives.
1.Toevaluate the retention of maxillary complete dentures fabricated using theconventional semifunctional technique and Compograph aided Posterior palatal seal using dynamometerretention test
2.To evaluate the clinical retention evaluation of maxillary complete denturesfabricated using the conventional semi functional technique and Compographaided Posterior palatal seal using functional tests at baseline and after sevendays.
3.To evaluate the clinical soft tissue changes seen on Posterior palatal sealarea after denture insertionat baseline and after observational period of 7 days for both the groups.
4.To compare the dynamometer retention readings and clinical retention testevaluations of maxillarycomplete dentures fabricated using the conventional semi functional technique andCompograph aided Posterior palatal seal technique within and between thegroups.
5.To compare the clinical changes of soft tissues under maxillary completedentures fabricatedusing the conventional semi functional technique and Compograph aided Posteriorpalatal seal technique within and between the groups.
Asample size of 17 patients was calculated for whom two sets for dentures shallbe fabricated. Patientswho report to Department of Prosthodontics and Crown & bridge, K. M. ShahDental College & hospital, Vadodara, and seek replacement of all missingteeth with complete denture prosthesis will be screened for inclusion andexclusion criteria of the study. All the patients who fit into the inclusionand exclusion criteria will be included after they sign a written informedconsent form available in three locallanguages (English, Hindi and Guajarati). All the required information aboutthe study shall be clearly stated to the patients through the patientinformation sheet (English, hindi and gujarati).
Two maxillary dentures shall befabricated for every patient. However, the denture to be inserted first shallbe decided on the basis of a randomised sequence using a computer generated randomizationtechnique. Based upon random allocation, the patientswould be given either of the two dentures. Denture insertion procedure shall bedone as per routine and evaluated for stability, phonetics, aesthetics andocclusion.
The Dynamometer Retentiontest, Clinical functional retention tests and clinical evaluation of softtissue in the PPS area shall be performed by a blinded evaluator on the day ofdenture insertion and 7 days after the denture delivery
On the seventhday after the first denture insertion, the first denture shall be taken awayfrom the participant. The participant shall now be placed on a washout periodof no denture wear for seven days. After this, the second denture as per theallocation sequence shall be inserted and the steps as followed for testing andfollow up evaluations shall be conducted by the same blinded evaluator afterseven days of use of second denture.
Thedata of retention tests and clinical soft tissue changes shall be entered inthe Proforma sheet
The ethicaland feasibility issues shall be addressed.
This study will help us to evaluate which of thetwo methods of establishing Posterior palatal seal is more beneficial withrespect to retention and post palatal soft tissue health. The same techniqueshall be recommended in further clinical practice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 17
Completely edentulous participants requiring removable complete dentures Patients with Type A Maxillary residual ridge morphology and Class I Complete edentulism based on the American College of Prosthodontists (ACP) classification Absence of any systemic disease that produce oral manifestations.
- Patients with implants or overdenture abutments in upper arch.
- Patients with maxillary edentulous ridges with no anterior and/or posterior undercuts Patients with excessive gag reflex.
- Patients with reduced salivary flow or having xerostomia Patients with known allergy to denture base material Presence of physical or psychological ailment that precludes recall visits like physically handicap Patients who have V shaped palatal vault Patients having any surgical or congenital maxillary defects Patients who are not willing to sign the consent form.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical retention On day of denture insertion and 7th day
- Secondary Outcome Measures
Name Time Method Clinical evaluation of soft tissue in palatal area On day of denture insertion and 7th day
Trial Locations
- Locations (1)
K M Shah Dental College
🇮🇳Vadodara, GUJARAT, India
K M Shah Dental College🇮🇳Vadodara, GUJARAT, IndiaDr Riddhi LalanPrincipal investigator9099230227riddhi.lln27@gmail.com