Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201610001837401 Date of Approval: 26/10/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of masticatory performance and patient satisfaction in lingualized versus monoplane occlusion schemes for complete denture wearers . Cross-Over Randomized Controlled Trial
Official scientific title Evaluation of masticatory performance and patient satisfaction in lingualized versus monoplane occlusion schemes for complete denture wearers . Cross-Over Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Background and rationale Treatment of edentulism with complete dentures is still employed widely because of its relative inexpensiveness and simplicity . Edentulous patients seek denture treatment to restore function and esthetics in the most comfortable fashion. A patient¿s quality of life is greatly affected by his /her satisfaction with complete denture. Complete dentures are made up of three surfaces ; impression (fitting ) surface , Polished surface and occlusal surface. Each of the three surfaces are all critical factors in the success of complete dentures and must be designed appropriately for each patient. The retention, stability and support of the dentures are governed by the design of these three surfaces If the fitting and polished surfaces are ideal, it is assumed that the form of the occlusal surfaces and the nature of their contacts become critical for successful denture function. Some authors believe that lingualized occlusion gives the patient improved comfort, function and appearance While others have proposed the use of flat teeth to minimize lateral forces and enhance denture stability. And patient may prefer due to being smoother to the tongue , feel , look and chew better The search for the most appropriate occlusal form and tooth arrangement for complete denture occlusion has been going on for almost two centuries. No strong evidence to recommend any type of chewing surfaces (occlusal schemes) for complete dentures. Objectives: The aim of this study is to investigate the effect of monoplane occlusion scheme versus lingualized occlusion scheme on the maticatory performance and patient satisfaction for patients restored with conventional complete denture. Research Hypothesis In completely edentulous patients restore
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied occlusion in complete denture wearers,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 11/10/2015
Actual trial start date 02/01/2016
Anticipated date of last follow up 03/06/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised The randomization sequence performed through the free random sequence generator on the web site "www.random.org" and obtain the numbers related to each group Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group lingualized occlusion one and half monthes lingualized occlusal scheme 100
Experimental Group monoplane occlusion scheme 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Patient's age ranging from 40 to 65 years old. 2-Patient with completely edentulous upper and lower arch with Angle's class I maxillomandibular relationship (ridge ). 3- General good health. 4-Healthy, well formed residual alveolar ridge covered with firm, relatively even compressible mucosa. Patients will be excluded from the study if one or more of the following criteria is/are present : 1-neuromuscular disorder 2-psychatric disorder. 3-patients with oral pathology including oral lesions and xerostomia.. 40 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/07/2015 faculty of oral and dental medicine , ethics comittee
Ethics Committee Address
Street address City Postal code Country
awal al maneal cairo 11553 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome masticatory performance 6 weeks after denture insertion
Secondary Outcome patient satisfaction ( VAS) pre operative , 6 weeks after denture insertion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of oral and dental medicine cairo university awal al manial street Cairo 11553 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mohamed gomaa (myself) 31 mohamed abdul khalek street Cairo 11894 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Oral and Dental Medicine Cairo University awal almaneal Cairo 11559 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Prof Dr Amal Kaddah awal al maneal Cairo 11559 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator AMAL KADDAH amal.kaddah@dentistry.cu.edu.eg 00201222181818 AWAL AL MANEAL ,Prosthodontic department faculty of oral and dental medicine
City Postal code Country Position/Affiliation
CAIRO 11555 Egypt head department prosthetic dentistry
Role Name Email Phone Street address
Public Enquiries mohamed farouk mfaroukabdulla@yahoo.com 00201006781407 awal al manial street , Faculty of oral and dental medicine ,Prosthetic department
City Postal code Country Position/Affiliation
CAIRO 11555 Egypt Ass Prof in Prosthetic department
Role Name Email Phone Street address
Scientific Enquiries AMAL KADDAH amal.kaddah@dentistry.cu.edu.eg 00201222181818 faculty oral and dental medicine awal al maneal
City Postal code Country Position/Affiliation
cairo 11559 Egypt Head department prosthetic dentistry
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information