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Comparison Between Acrylic and Soft Liner Telescopic Overdentures Regarding Patient Satisfaction

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ClinicalTrials.gov Identifier: NCT03127033
Recruitment Status : Unknown
Verified April 2017 by Yasmine Hisham Abd El rahman Mohsen, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : April 25, 2017
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Yasmine Hisham Abd El rahman Mohsen, Cairo University

Brief Summary:
Conventional complete overdenture will be made to ectodermal dysplasia patients, a week after delivery and after 3 months Patient satisfaction, retention and periodontal condition will be assessed. the denture will be taken from the patient for 2 weeks.Acrylic telescopes will be replaced with soft liner and again Patient satisfaction, retention and periodontal condition will be assessed a week after delivery and 3 months later.

Condition or disease Intervention/treatment Phase
Patient Satisfaction Retention Periodontal Health Other: Soft liner telescopes Not Applicable

Detailed Description:

Upper and Lower Primary impressions will be carried out by using irreversible hydrocolloid (Alginate, Tropicalgin, Normal setting, Zhermack, Italy) according to manufacturer's instructions using stainless steel stock trays.

Secondary upper impression is done with an acrylic special tray. Border molding is done with putty consistency rubber base impression material, Final impression with medium consistency rubber-base impression material (Silicone impression material, Elite P&P, Regular Body-Normal set, Zhermack, Italy) Maxilla-mandibular relationship will be recorded using check bite technique. Setting of artificial teeth will be performed and trial dentures will be tried in inside patients' mouth.

The finished and polished dentures will be delivered immediately after the necessary occlusal adjustments and instructions regarding hygiene and maintenance.

The patient will use the upper overdenture for 3 months. The overdenture is taken from the patient for two weeks, after which the maxillary overdenture will be adjusted by relieving acrylic opposite to the abutment about 2 mm using a metal stone. The relieved areas will be painted with an adhesive and the rest of the fitting surface of the denture will be painted with a separating medium.

The soft liner (Silicone based soft liner, mollosil, chairside soft relining-long term, DETAX, Germany) will then be applied in the relieved areas to act as a secondary coping The base and catalyst will be mixed according to the manufacturer's instructions on a glass slab. The mix will be placed on the relieved area, seated in the patient's mouth, the patient is asked to bite in centric relation and the excess liner is removed with a lancet.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Patient Satisfaction of Soft Liner Versus Acrylic Resin Telescopes in Complete Overdenture Patients With Ectodermal Dysplasia: Non-Randomized Clinical Trial
Estimated Study Start Date : May 1, 2017
Estimated Primary Completion Date : August 1, 2017
Estimated Study Completion Date : November 1, 2017



Intervention Details:
  • Other: Soft liner telescopes

    Soft liner telescopes: Overdenture will be adjusted by relieving acrylic opposite to the abutment about 2 mm using a metal stone. The relieved areas will be painted with an adhesive and the rest of the fitting surface of the denture will be painted with a separating medium.

    The soft liner (Silicone based soft liner, mollosil, chairside soft relining-long term, DETAX, Germany) will then be applied in the relieved areas to act as a secondary coping The base and catalyst will be mixed according to the manufacturer's instructions on a glass slab. The mix will be placed on the relieved area, seated in the patient's mouth, the patient is asked to bite in centric relation and the excess liner is removed with a lancet.



Primary Outcome Measures :
  1. Patient Satisfaction [ Time Frame: 3 months ]
    A questionaire will be given to the patient to assess thier denture satisfaction in numerical data using Visual Analogue Scale


Secondary Outcome Measures :
  1. Retention [ Time Frame: 3 months ]
    Retention will be assessed subjectively using Kapur's retention scoring system in ordinal data.

  2. Gingival index [ Time Frame: 3 months ]
    periodontium condition will be assessed through Gingival index scoring system in ordinal data

  3. Probing depth [ Time Frame: 3 months ]
    Probing depth will be measured using periodontal probe in Mm

  4. Tooth mobility [ Time Frame: 3 months ]
    tooth mobility will be assessed through periostest using Periotest value.

  5. Absence or presence of inflammation [ Time Frame: 3 months ]
    Absence or presence of inflammation will be assessed visually as a binary outcome



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Ages Eligible for Study:   6 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Partially edentulous ectodermal dysplasia patients with few remaining teeth.
  2. Cooperative patients with no history of psychological diseases.
  3. Length of maxillary remaining teeth should not be less than 4mm.

Exclusion Criteria:

- 1- Patients with tempo-mandibular joint disorders or systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.

2- Patients allergic to acrylic resin.


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Responsible Party: Yasmine Hisham Abd El rahman Mohsen, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03127033     History of Changes
Other Study ID Numbers: 171088
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No