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.: PACTR202307729042647 Date of Approval: 12/07/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of three attachment systems for mandibular and maxillary implant overdentures: A Randomized Clinical trial
Official scientific title Evaluation of three attachment systems for mandibular and maxillary implant overdentures: A Randomized Clinical trial
Brief summary describing the background and objectives of the trial Background: Implant supported overdenture improves on the drawbacks of conventional complete denture, providing improve retention, oral health and quality of life. There are some debatable factors to be considered for the success of implant supported dentures especially for the choice of an implant attachment that gives the desired long term maintenance outcome. These long-term maintenances are loss of retention, plaque accumulation, fracture of prosthesis, attachments and implants. A new abutment locator R-Tx was developed recently to give good clinical outcome but there are concerns of long-term maintenance such as rapid loss of retention and plaque accumulation. The aim of this study is to determine the long-term maintenance of implant abutment system such as retention, plaque accumulation, fracture of implant abutment of ball, bar, locator R-Tx system and to compare the long-term maintenance of these 3 abutment systems. OBJECTIVES 1.To determine the force required to dislodge implant overdenture from attachment using locator R-Tx , Ball and Bar attachments. 2.To determine the level of plaque accumulation on implant- attachment surface using locator R-Tx , Ball and Bar attachments. 3.To compare the force required to dislodge implant overdenture from locator R-Tx , Ball and Bar attachments. 4.To compare the level of plaque accumulation on implant- attachment surface using locator R-Tx , Ball and Bar attachments.. 5.To determine secondary outcomes/Complications involving attachment or prostheses.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/08/2023
Actual trial start date 08/08/2023
Anticipated date of last follow up 04/08/2024
Actual Last follow-up date 09/08/2024
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Active, not 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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group use of ball implant attachment system 2 ball attachment placed on lower arch and 4 ball attachments placed. on upper arch 18 months Ball Implant attachment are placed on implant sank in residual alveolar ridge and fabricated complete dentures are fitted on these attachments to enhance retention. 20 Active-Treatment of Control Group
Experimental Group Locator R system Two is placed on lower alveolar residual ridge and 4 on upper alveolar residual ridge. 18 months Locator R-Tx system is placed on dental implant sank in residual ridge, fabricated complete denture is then fitted on the abutment system. 20
Experimental Group Bar attachment system Two attachments are placed on lower alveolar residual ridge and four attachments are placed on upper alveolar residual ridge. 18 months The bar attachment is placed on dental implant sank in alveolar residual ridge and then fabricated complete denture is fitted on implant attachment system. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
INCLUSION CRITERIA 1. Consenting Older adults aged 60 years and above with complete edentulous residual ridge attending the Department of Restorative Dentistry, Lagos University Teaching Hospital, Lagos, Nigeria. 2. Older adults aged 60 years and above with complete edentulous residual ridge attending the Department of Restorative Dentistry, Lagos University Teaching Hospital, Lagos, Nigeria who give informed verbal consent. 3. Older adults aged 60 years and above with complete edentulous residual ridge attending the Department of Restorative Dentistry, Lagos University Teaching Hospital, Lagos, Nigeria who are not heavy smokers, who do not have uncontrolled systemic or debilitating disease. 4. Patients with adequate bone volume (radiographic bone quality of Type 1 to 3) and with a complete edentulous maxilla or mandible. 5. Patients with adequate interarch space( minimum of 12mm) 1.Older adults aged 60 years and above with partial edentulous residual ridge attending Department of Restorative Dentistry, Lagos University Teaching Hospital, Lagos, Nigeria who decline informed verbal consent. 2.Older adults aged 60 years and above with complete edentulous residual ridge attending the Department of Restorative Dentistry, Lagos University Teaching Hospital, Lagos, Nigeria 3.Older adults aged 60 years and above with complete edentulous residual ridge attending the Department of Restorative Dentistry, Lagos University Teaching Hospital, Lagos, Nigeria who have radiographic evidence of lesions that preclude implant placement or patient undergoing radiotherapy 4.Patients with uncontrolled systemic health problems, coronary heart disease or cerebral vascular incidents within the previous 6 months will be excluded. Patients smoking more than 20 cigarettes per day will also be excluded. 5. Non consenting Patients 6. Patients with reduced interarch space (less than 12mm) 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 60 Year(s) 90 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
No 08/02/2023 Lagos University Teaching Hospital Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Idi Araba, Lagos Lagos 100254 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Retention Measured as force required to dislodge the complete denture. This will be measured using a gauge attached to denture and face bow placed on participants face. Recording is done by taking 5 readings and determining the mean score.2. Plaque accumulation Determined by standard scoring scale- Modified Quigley-Hein visual scoring Scale-. Baseline, recall visits at 3, 6, 9, 12, 15 and 18 months.
Secondary Outcome Records of Complication such as 1.Looseness of Patrix 2.Activation of Patrix 3.Replacement of Patrix 4.Fractured Patrix 5.Dislodged or worn or loose matrix or housing 6.Activation of matrix and frequency of activation 7.Replacement of matrix, frequency of replacement and location. 8.Fracture of matrix 9.Fracture of overdenture prosthesis or fracture of acrylic resin over Patrix, or fractured denture teeth 10.Reline of overdenture prosthesis 11.New construction of overdenture 12.Peri-implant or mucosal enlargement will all be recorded. baseline, at recall visits of 3, 6, 9, 12, 15 and 18 months. Data will be entered at the 19th month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital Idi Araba Lagos 100254 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Lagos Central Research Committee Grant Akoka Lagos 100213 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University Of Lagos Central Research Grant Committee Akoka Lagos 100213 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Temitope Ayodele Esan Obafemi Awolowo University Ile Ife 220101 Nigeria
Wasiu Lanre Adeyemo University Of Lagos Lagos 100213 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bolanle Akinboboye bakinboboye@unilag.edu.ng 07057251024 6 Awoseyin street, Shomolu
City Postal code Country Position/Affiliation
Lagos 100001 Nigeria Associate Professor University of Lagos
Role Name Email Phone Street address
Public Enquiries Wasiu Adeyemo wadeyemo@unilag.edu.ng 08091513026 University of Lagos, Akoka
City Postal code Country Position/Affiliation
Lagos Nigeria Professor of Oral and Maxillofacial Surgery University of Lagos Akoka
Role Name Email Phone Street address
Scientific Enquiries Oyinkan Sofola oysofola@yahoo.com 08033031483 Lagos University Teaching Hospital, Idi Araba
City Postal code Country Position/Affiliation
Lagos Nigeria Professor Community Dentistry University of Lagos
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification will be made available. Individual participant data that underlie the results reported in this study, after deidentification will also be made available in form of text, tables, figures, and appendices. Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Statistical Analysis Plan will also be made available. All data will be made available within 6 months of publication and end 3 years after publication. Data will be made available to Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data is to be used by researchers who provide a methodologically sound proposal and investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. The data is to be used to achieve aims in the approved proposal. Data will be made available after 3 years in the university of Lagos data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at webteam@unilag.edu.ng Informed Consent Form,Statistical Analysis Plan 6months to 3 years of publication researchers who provide a methodologically sound proposal and investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information