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

Cairo University (CU)

Status: Completed

Conditions: Tumour

Treatments: Other: attachment retained obturator; Other: clasp retained obturator

Study type: Interventional

Funder types: Other

Identifiers

NCT03146624

201512

Details and patient eligibility

About

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

Full 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"

Enrollment: 14 patients

Sex: All

Volunteers: No Healthy Volunteers

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 .

Exclusion criteria

1- patients are exposed to radiotherapy or chemotherapy.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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14 participants in 2 patient groups

attachment

Experimental group

Description:

attachment retained obturator

Treatment:

Other: attachment retained obturator

clasp

Active Comparator group

Description:

clasp retained obturator

Treatment:

Other: clasp retained obturator