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.: PACTR201803003085193 Date of Approval: 12/02/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title protocol for a randomized controlled trial.
Official scientific title The impact of healing protocol and attachment type for single-implant retained mandibular complete dentures: protocol for a randomized controlled trial.
Brief summary describing the background and objectives of the trial Background: It has been shown that for edentulous patients a single mandibular implant is sufficient to retain a complete mandibular denture. Single implants provide a satisfactory survival rate, when they heal submerged. Moreover, this cost-effective treatment option would benefit the patients by saving the pain associated with the second stage surgery by using non-submerged healing. Ball attachments have been commonly used to retain the single-implant retained overdenture. However, they require considerable maintenance and may show loss of retention overtime, requiring substantial maintenance efforts.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Edentulism,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 02/01/2016
Actual trial start date 03/03/2016
Anticipated date of last follow up 11/10/2021
Actual Last follow-up date 12/02/2022
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Closed to recruitment,follow-up continuing
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 Sealed opaque envelopes Open-label(Masking Not Used) Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group healing protocol during implant installation for 3 month after implant installation healing protocol during implant installation ; submerged and non submerged 40
Experimental Group attachment 3 month after implant installation for 5 years attachment type 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Completely edentulous male or female patients between the ages of 50 to 69. - No contraindications for implantation. - Each patient has to perform both a random blood sugar and Glycosylated Hemoglobin analysis. Patients with a Glycosylated hemoglobin test HbA1c up to 8% and a normal blood sugar level (79 to 110) or controlled diabetes (90-130 fasting according to American Association of Diabetes) will be included. - Sufficient bone width (¿ 5 mm) in the anterior region to place an implant. It could be either normally present or achieved by bone plateauing. This will be confirmed by cone beam computed tomographic (CBCT) scans. - Residual bone height is 11-20 and 13 mm as the lowest vertical height of the mandible and the lowest vertical bone height in the midline of the mandible, respectively (Class II or III according to McGarry et al. 1999. - Patients seeking to install a single median implant in the mandible and for whom new dentures will be constructed. - Patients, who are dissatisfied with the retention and stability of their technically satisfactory mandibular dentures. - Patients, who already have existing maxillary and mandibular complete dentures, and after examination of the mandibular dentures, it is found that there are technical problems with regard to denture design and/or occlusion; then new maxillary and mandibular dentures will be fabricated. - All patients should have adapted to their dentures for at least six weeks before being included in the trial. - Provide a written consent to participate in the trial, and this will be done before the scheduled date for implant installation. - Patients with a systemic or local contra-indication for implant placement. - Satisfied patients with the retention of their mandibular denture as well as unsatisfied patients with their maxillary denture. - Patient with a mandibular denture height less than 6 mm between the base of the denture and the incisal edge of the central incisors (this was measured by a caliper). - Patients who are classified as Class I, or IV according to McGarry et al. 1999. - Incompliant and not cooperative patients. - Patients with an implant stability less than 60 ISQ (this is not an exclusion criteria in this phase, this would be considered during implant installation). 50 Year(s) 69 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 13/06/2016 Research Ethics Committee, Faculty of Oral & Dental Medicine
Ethics Committee Address
Street address City Postal code Country
11 El saraya street cairo
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome patient satisfaction 2 weeks after loading , 6 month , 12 month follow up and annually for 5 years
Primary Outcome patient quality of life 2 weeks after pick up, 6 month , 12 month annually for 5 years
Primary Outcome chewing ability 2 weeks after pick up, 6 month , 12 month annually for 5 years
Primary Outcome Retention 6 month , 12 month annually for 5 years
Primary Outcome Implant sucess , survival and failure 1 year follow up and then annually for 5 years
Secondary Outcome soft tissue reaction 6 month , 12 month after loading and then annually for 5 years
Secondary Outcome Marginal bone height changes 1 year follow up , and then after 3 years and then after 5 years
Secondary Outcome maintennace 2 weeks after pick up, 6 month , 12 month annually for 5 years
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
out patient clinic - Removable prosthodontic department -cairo university 11 Elsaraya street, manial, cairo , Egypt cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Four PHD students 11 Elsaraya street, manial , cairo, Egypt cairo Egypt
DAAD organization 37 MarkgrafenstraBe Berlin 10117 Germany
STDF Organization 101 el kasr el Aini street cairo Egypt
Cendres +Metaux 122 street Rue de Boujean Bienne CH-2501 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Four PHD Students 11 el saraya street , manial cairo Egypt cairo Egypt University
Primary Sponsor prosthodontic department 11 el saraya street , manial cairo Egypt cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
nouran abdel nabi 11 el saraya street , manial cairo Egypt cairo Egypt
karim Foda 11 el saraya street , manial cairo Egypt cairo Egypt
marwa abdel Al 11 el saraya street , manial cairo Egypt cairo Egypt
ahmed salah 11 el saraya street , manial cairo Egypt cairo Egypt
Saad Chaar Christian-Albrechts University of Kiel Kiel Germany
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator nouran abdel nabi nouranabdelnabi@hotmail.com 02-01001539310 11 elsaraya , manial, Egypt
City Postal code Country Position/Affiliation
cairo Egypt Lecturer in removable prosthodontic department
Role Name Email Phone Street address
Principal Investigator saad chaar schaar@proth.uni-kiel.de 0049-17662024196 Christian-Albrechts University of Kiel
City Postal code Country Position/Affiliation
kiel Germany Assosiate professor -Christian-Albrechts University of Kiel
Role Name Email Phone Street address
Public Enquiries Marwa Abdel Al marwa.abdelaal@gmail.com 02-01147940889 11 elsaraya , manial, Egypt
City Postal code Country Position/Affiliation
cairo Egypt assistant lecturer -removable prosthodontic department -Cairo University
Role Name Email Phone Street address
Scientific Enquiries Matthias Kern mkern@proth.uni-kiel.de 0049-4315972874 Christian-Albrechts University of Kiel
City Postal code Country Position/Affiliation
Germany Professor -Christian-Albrechts University of Kiel
Role Name Email Phone Street address
Scientific Enquiries khaled zekry khaledzekry@hotmail.com 02-01222189729 11 elsaraya , manial, Egypt
City Postal code Country Position/Affiliation
cairo Egypt professor od removable prosthodontic department
REPORTING
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Result URL Hyperlinks
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