Evaluation of Patients Satisfaction of Attachment Retained Versus Clasp Retained Obturators in Unilateral Total Maxillectomy

Study Overview
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Brief Summary
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OBJECTIVE to evaluate patients satisfaction of obturator with attachment versus conventional obturator in treatment of unilateral maxillectomy .

Detailed Description
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Fourteen patients were selected according to the following criteria : patients having sufficient number of natural teeth(class I and \or class IV Aramany classification)not less than five teeth, intact soft palate , sufficient mouth opening , not exposed to radiotherapy or chemotherapy. Patients were divided into two equal groups, each of seven patients: patients of group I(Comparator) received a clasp retained obturator, while patients of group II(Intervention) received an attachment-retained obturator (RCT). The design of the definitive obturator for group I included double Aker's clasp on the first , second premolars and molars with alternating buccal and lingual retention, palatal plate as a major connector and a meshwork extension at the defect side. For group II, crown preparation of all the remaining abutments was done. Then, in the wax pattern, a lingual guiding plane was prepared and two OT Vertical attachments were attached mesial to the most anterior abutment and palatal to the second premolar and first molar . Construction of the splinted crowns were completed and the final impression was made with the splinted crowns in place to be picked up into the impression. After final try-in of the obturator, construction of the definitive obturator was completed with a hard resin hollowed obturator bulb, functional relining with soft silicone liner for both groups. Evaluation included patient satisfaction (primary outcome)where Two scales were followed in this study which areThe Obturator Functioning Scale and  The European Organization for Research and Treatment of Cancer Head and Neck 35

Official Title
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Evaluation of Patients Satisfaction of Attachment Retained Versus Clasp Retained Obturators in Unilateral Total Maxillectomy

Conditions
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Tumour

Intervention / Treatment
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* Other: attachment retained obturator
* Other: clasp retained obturator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - patients with sufficient number of natural teeth(class I and \or class IV Aramany classification), - intact soft palate, 3- the mouth opening is not less than 25 mm . Exclusion Criteria: 1- patients are exposed to radiotherapy or chemotherapy.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: attachment<br>attachment retained obturator | Other: attachment retained obturator<br>* obturator which retained by attachment<br>* Other names: obturator with attachment;|
| Active Comparator: clasp<br>clasp retained obturator | Other: clasp retained obturator<br>* obturator which retained by clasp<br>* Other names: obturator with clasp;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction | questionnairesThe Obturator Functioning Scale | 1 month | 
| patient satisfaction | questionnaires  The European Organization for Research and Treatment of Cancer Head and Neck 35 | 1 month |