Comparison Between Acrylic and Soft Liner Telescopic Overdentures Regarding Patient Satisfaction

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03127033
Collaborator
(none)
6
6

Study Details

Study Description

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
  • Other: Soft liner telescopes
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
May 1, 2017
Anticipated Primary Completion Date :
Aug 1, 2017
Anticipated Study Completion Date :
Nov 1, 2017

Outcome Measures

Primary Outcome Measures

  1. Patient Satisfaction [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 [3 months]

    Retention will be assessed subjectively using Kapur's retention scoring system in ordinal data.

  2. Gingival index [3 months]

    periodontium condition will be assessed through Gingival index scoring system in ordinal data

  3. Probing depth [3 months]

    Probing depth will be measured using periodontal probe in Mm

  4. Tooth mobility [3 months]

    tooth mobility will be assessed through periostest using Periotest value.

  5. Absence or presence of inflammation [3 months]

    Absence or presence of inflammation will be assessed visually as a binary outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yasmine Hisham Abd El rahman Mohsen, Principal investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT03127033
Other Study ID Numbers:
  • 171088
First Posted:
Apr 25, 2017
Last Update Posted:
Apr 25, 2017
Last Verified:
Apr 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 25, 2017