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

Tumour Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03146624
• Other study ID #: 201512
• Status: Completed
• Phase: N/A
• First received: May 4, 2017
• Last updated: May 9, 2017
• Start date: December 1, 2015
• Est. completion date: March 28, 2017

Study information

• Verified date: May 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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"

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 28, 2017
• Est. primary completion date: February 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Tumour

Intervention

Other:
• attachment retained obturator
obturator which retained by attachment
• clasp retained obturator
obturator which retained by clasp

Locations

Country	Name	City	State
Egypt	Mohamed Yahia Sharaf	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient satisfaction	questionnaires"The Obturator Functioning Scale"	1 month
Primary	patient satisfaction	questionnaires " The European Organization for Research and Treatment of Cancer Head and Neck 35"	1 month