TumourNCT03146624
Evaluation of Patients Satisfaction of Attachment Retained Versus Clasp Retained Obturators in Unilateral Total Maxillectomy
A study testing attachment retained obturator and clasp retained obturator in people with Tumour, run by Cairo University at 1 site in Egypt.
Trial summary
OBJECTIVE to evaluate patients satisfaction of obturator with attachment versus conventional obturator in treatment of unilateral maxillectomy . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tumour
- What is being tested?
- attachment retained obturator and clasp retained obturator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2015to 28 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- - 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 .
Who cannot join
- 1- patients are exposed to radiotherapy or chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
OBJECTIVE to evaluate patients satisfaction of obturator with attachment versus conventional obturator in treatment of unilateral maxillectomy .
Read the 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"
- Conditions
- Tumour
- Being tested
- attachment retained obturator, clasp retained obturator
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
attachment retained obturatorOther
Also called obturator with attachment
obturator which retained by attachment
clasp retained obturatorOther
Also called obturator with clasp
obturator which retained by clasp
| Study group | Role | What they receive |
|---|---|---|
| attachment | Experimental | attachment retained obturator Receives: Other: attachment retained obturator |
| clasp | Active comparator | clasp retained obturator Receives: Other: clasp retained obturator |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
questionnaires"The Obturator Functioning Scale"
Measured: 1 month
patient satisfaction
questionnaires " The European Organization for Research and Treatment of Cancer Head and Neck 35"
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 Dec 2015
- Primary completion21 Feb 2017
- Study completion28 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumourStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharaf Mohamed Yahia, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146624
- Sponsor's protocol ID
- 201512
- Status last verified
- May 2017
- First submitted
- 4 May 2017
- Last updated
- 10 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patients Satisfaction of Attachment Retained Versus Clasp Retained Obturators in Unilateral Total Maxillectomy
- ClinicalTrials.gov ID
- NCT03146624
- Acronym / sponsor ID
- 201512
- Conditions
- Tumour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 21 Feb 2017 (actual)
- Study completion
- 28 Mar 2017 (actual)
- First posted
- 10 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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"
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| attachment | Experimental | Other: attachment retained obturatorattachment retained obturator |
| clasp | Active comparator | Other: clasp retained obturatorclasp retained obturator |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- - 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 .
Key exclusion criteria (1 listed)
- 1- patients are exposed to radiotherapy or chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| attachment retained obturatorAlso: obturator with attachmentobturator which retained by attachment | Other | attachment |
| clasp retained obturatorAlso: obturator with claspobturator which retained by clasp | Other | clasp |
Primary outcome
patient satisfaction
Time frame: 1 month
questionnaires"The Obturator Functioning Scale"
patient satisfaction
Time frame: 1 month
questionnaires " The European Organization for Research and Treatment of Cancer Head and Neck 35"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing attachment retained obturator and clasp retained obturator in people with Tumour, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.