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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03146624
Enrollment
14
Registered
2017-05-10
Start date
2015-12-01
Completion date
2017-03-28
Last updated
2017-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumour

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

Interventions

OTHERattachment retained obturator

obturator which retained by attachment

OTHERclasp retained obturator

obturator which retained by clasp

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
patient satisfaction1 monthquestionnairesThe Obturator Functioning Scale

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026