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

Not Applicable

Completed

• Conditions: Tumour
• Interventions: Other: clasp retained obturator; Other: attachment retained obturator

• Registration Number: NCT03146624
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

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 are"The Obturator Functioning Scale" and " The European Organization for Research and Treatment of Cancer Head and Neck 35"

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-12-01
• Primary Completion: 2017-02-21
• Study Completion: 2017-03-28
• Status Verified: 2017-05
• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-09
• Last Update Submitted: 2017-05-09
• Study First Posted: 2017-05-10
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. • patients with sufficient number of natural teeth(class I and \or class IV Aramany classification),
2. • intact soft palate, 3- the mouth opening is not less than 25 mm .

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Exclusion Criteria

1- patients are exposed to radiotherapy or chemotherapy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
clasp	clasp retained obturator	clasp retained obturator
attachment	attachment retained obturator	attachment retained obturator

Primary Outcome Measures

Name	Time	Method
patient satisfaction	1 month	questionnaires " The European Organization for Research and Treatment of Cancer Head and Neck 35"

Trial Locations

Locations (1)

Mohamed Yahia Sharaf; 🇪🇬 Cairo, Egypt