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Completed

NCT Number: NCT03146624

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

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

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohamed Yahia Sharaf

Cairo, 11599, Egypt

About this study

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"

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

attachment retained obturator

Other

obturator which retained by attachment

Other names: obturator with attachment

clasp retained obturator

Other

obturator which retained by clasp

Other names: obturator with clasp

Primary outcomes

  1. patient satisfaction

    Time frame: 1 month

    questionnaires"The Obturator Functioning Scale"

  2. patient satisfaction

    Time frame: 1 month

    questionnaires " The European Organization for Research and Treatment of Cancer Head and Neck 35"

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 10, 2017
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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