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.: PACTR202209543461078 Date of Approval: 16/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of Flapless Dental Implant Placement in Controlled Type 2 Diabetic Patients (A Randomized Controlled Clinical Trial)
Official scientific title Evaluation of Flapless Dental Implant Placement in Controlled Type 2 Diabetic Patients (A Randomized Controlled Clinical Trial)
Brief summary describing the background and objectives of the trial Dental implantation is a routine procedure with a very high success rate in the rehabilitation of partial or complete teeth loss. However, dental implantation is a highly aggressive procedure, which causes postoperative inflammation and bone resorption. The relationship between a full thickness flap elevation and peri-implant bone loss was documented in 1960s. The postoperative complications due to full-thickness flap had led to the rising of minimally invasive techniques for implant placement. Diabetes mellitus was once a contraindication for dental implantation because it has been related to several complications, including increased risk of infection, poor wound healing, and microvascular and macrovascular complications. The effectiveness of flapless techniques has been supported by different studies. However, The results are sometimes contradictory and that is why we need more controlled clinical studies are needed to minimize bias. The present study is conducted to evaluate the efficacy of the guided flapless technique for dental implant placement in the maxillary posterior area in controlled type 2 diabetic patients in terms of clinically regarding pain, swelling implant stability, and radiologically regarding crestal bone loss around the dental implant.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/11/2021
Actual trial start date 01/11/2021
Anticipated date of last follow up 30/09/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL N/A
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 randomization Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Flapless dental implant N/A Once at time of implant insertion, Then once after 4 months (crown placement) Dental implant placement in maxillary posterior area by flapless technique 10
Control Group Flap dental implant N/A Once at the time of implant insertion, Then once after 4 months (crown placement) Dental implant placement in maxillary posterior area by conventional (flap)technique 10 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Diabetic patients with glycosylated hemoglobin (HbA1C) levels of less than 7%. Absence of microvascular complications of diabetes (such as nephropathy, neuropathy, and retinopathy). The extraction site healed for at least 6 months in the posterior maxillary molar area. Sufficient bone height and width. Adequate keratinized gingiva (KG)  (>2 mm). Patient with uncontrolled glycemic index (HBA1c > 7 %). Patients with acute infection or with relevant systemic diseases or local factors which contraindicate implant placement. patients with parafunctional habits such as bruxism, clenching……etc. Patients with poor oral hygiene, and heavy smokers. Symptoms of generalized periodontitis. bone augmentation procedure before or during implant placement. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 60 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 19/09/2021 Institutional Review Boards IRB at the faculty of dentistry Alexandria University IRB NO 00010556 IORG 0008839
Ethics Committee Address
Street address City Postal code Country
Champollion St., Azarita Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Marginal bone loss Immediate postoperative, After 4 months, After 8 months.
Secondary Outcome Implant stability (ISQ) Immediate at time of implant insertion, After 4 months.
Secondary Outcome VAS Scale for Pain After 1, 3, 7 days.
Secondary Outcome Swelling After 1, 3, 7 days.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient Clinic of Alexandria University Teaching Hospital and operated in the Oral and Maxillofacial Surgery Department Faculty of Dentistry Alexandria University Champollion Street, Qesm Bab Sharqi, Azarita Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Elsayed ElSaa Square Victoria Alexandria 21533 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oral and Maxillofacial Surgery Department Faculty of Dentistry Alexandria University Champolion St., Azarita Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mahitab Soliman 88 Abdelslam Aref street , gleem Alexandria 21648 Egypt
Mohamed Shokry 17 Champolion St., Azarita Alexandria 21521 Egypt
Ahmed Elsayed ElSaa Square Victoria Alexandria 21533 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahitab Soliman mahisolim55@gmail.com 00201282243346 88 Abdelslam Aref street , gleem
City Postal code Country Position/Affiliation
Alexandria 21648 Egypt Professor of Oral and Maxillofacial Surgery Oral and Maxillofacial Surgery Department Faculty of Dentistry Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Shokry moh_shokry@gmail.com 00201113290990 17 Champollion street Al Mesallah Sharq, Al Attarin
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt AssociateProfessor of Oral and Maxillofacial Surgery Oral and Maxillofacial Surgery Department Faculty of Dentistry Alexandria University
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes A full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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