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.: PACTR201701001214873 Date of Approval: 23/07/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of CAD-CAM designed telescopic crown retainers
Official scientific title Impact of CAD-CAM designed telescopic crown retainers versus conventional clasps on the Quality of Life and Muscle Activity for Patients Restored by Mandibular distal extension removable partial dentures
Brief summary describing the background and objectives of the trial Posterior distal extension partial denture bases present a number of design challenges. Of particular concern is the equitable distribution of forces that may become adverse during functional and parafunctional activities to maintain remaining alveolar ridges and teeth in an optimal state of health and to provide the patient with improved comfort and function, These forces are often compensated for to some extent by framework and denture base design variation. Telescopic crown is used to provide support, retention and stability for removable partial or complete dentures. They also provide improved functions as compared to the conventional dentures, such as an improved biting force, chewing efficiency and even phonetics. Telescopic crowns have proven more effective than other direct retainers. Their degree of retention can be planned to suit different situations by modifying the design, Telescope crowns are used to retain partial dentures provide the best possible force distribution to the abutment teeth and improve patients oral health-related quality of life. The fabrication of complete dentures using a computer-aided design/computer-aided manufacturing (CAD/CAM) system has the potential to simplify the above process and resolve the associated problems. In recent years, CAD/CAM systems have been successfully introduced into restorative dentistry and maxillofacial technology.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mandibular distal extension removable partial dentures
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 24/07/2015
Actual trial start date 24/07/2015
Anticipated date of last follow up 24/07/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation sealed block envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group RPOD retained by Telescopic crowns designed by CAD CAM system once along the research time Telescopic crowns have proven more effective than other direct retainers. Their degree of retention can be planned to suit different situations by modifying the design, Telescope crowns are used to retain partial dentures provide the best possible force distribution to the abutment teeth and improve patients oral health-related quality of life 21 Active-Treatment of Control Group
Control Group RPOD retained by conventional clasp designed with CAD CAM system once along the researh time conventional clasp is reverse aker lasp on the first premolar teeth 21 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Age 45-65 years. With mean age of 55 years 2- Partially edentulous mandible with remaining first premolars and six anterior teeth with healthy periodontal condition and good oral hygiene. 3- All abutments will be had adequate amount of bone support. 4-Residual alveolar ridges will be of suitable height, covered with healthy, relatively moderate thickness and firm mucosa. 5- Normal maxillomandibular relation. 6- Sufficient inter-arch space especially the posterior region, this will be verified by recording a tentative jaw relation. 7- the time lapsed from last extraction is at least one year. 8- No neurological disorders. 9- Be physically and psychologically able to tolerate procedures. 10- Be cooperative to return for follow-up, examinations and evaluation 1. Patients with poor oral hygiene and motivation. Because poor oral hygiene can cause inflammation which induce pain that effect OHIP questionnaire outcome. 2.Patients with systemic disease such as endocrine and metabolic diseases (ex: Diabetes Mellitus). Because these diseases increase bone resorption which affect the periodontal support of abutments. 3.Patients will be also free of tempro-mandibular disorders (TMD). Because TMD patients characterize by asymmetrical jaw movements which resulting in altered masticatory dynamics that is responsible for electromyograph misleading readings. 4. Psychiatric problems or unrealistic expectations. Because they cannot able to tolerate procedures. 45 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 08/06/2015 Ethical committee for scientific researches
Ethics Committee Address
Street address City Postal code Country
11 Elsaraya street, Manyal Cairo 12611 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Oral Health Related Quality of Life T0: at time of mandibular partial denture insertion. T3: after 3 monthes , of mandibular partial denture insertion. T6: After 6 monthes , of mandibular partial denture insertion
Secondary Outcome muscle ativity T0: at time of mandibular partial denture insertion. T3: after 3 monthes , of mandibular partial denture insertion. T6: After 6 monthes , of mandibular partial denture insertion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of dentistry, Cairo university 11 Elsaraya street, Manyal Cairo 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding 55 Ali ben Abi Taleb street Mansoura 35524 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of dentistry 11 Elsaraya street, Manyal Cairo 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amal Fathy Kaddah 11 Elsaraya street, Manyal Cairo 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Keshk dr_magic_pearl@Hotmail.com 0201002220394 55 Ali ben Abi Taleb street
City Postal code Country Position/Affiliation
Mansoura 35524 Egypt dentist, Egyptian Ministry of Health
Role Name Email Phone Street address
Public Enquiries Radhwan Saleh Algabri radalgabri@yahoo.com 00201157889674 6 Abdobadran ¿ Manyal
City Postal code Country Position/Affiliation
Cairo 12613 Egypt PhD researchers coordinator
Role Name Email Phone Street address
Scientific Enquiries Ahmed Keshk dr_magic_pearl@hotmail.com 0020100220394 55 Ali ben Abi Taleb street
City Postal code Country Position/Affiliation
Mansoura 35524 Egypt dentist, Egyptian Ministry of Health
REPORTING
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