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.: PACTR202101511724343 Date of Approval: 21/01/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Antibiotic prophylaxis protocol to prevent postoperative complications in uncontrolled diabetic patients undergoing simple teeth extractions: A randomized, double-blind, single-center trial
Official scientific title Antibiotic prophylaxis versus placebo in uncontrolled diabetic patients undergoing teeth extraction: a double-blind, randomized trial
Brief summary describing the background and objectives of the trial According to recent study; the occurrence of postoperative infectious following simple teeth extraction seems not be significantly higher in uncontrolled diabetic patients comparing to healthy people. Infact, many other factors may compromise mucosal healing especially the poor oral hygiene and bacterial plaque accumulation. In addition, the wide use of antibiotics all over the world has produced two important negative effects: selection and quick development of antibiotic resistant bacterial strains; increase of allergic reactions to antibiotics. Having hypothesized that uncontrolled diabetic patients should not receive antibiotic prophylaxis simply because of their status, we conducted this study toinvestigate whether antibiotic prophylaxis would reduce the incidence of postoperative complications following simple teeth extraction.
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 Treatment: Drugs
Anticipated trial start date 01/02/2021
Actual trial start date 01/02/2021
Anticipated date of last follow up 30/09/2021
Actual Last follow-up date 30/09/2021
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants)
Recruitment status Not yet 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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo patients will receive 2 gram placebo one hour before and 6 days following the dental extraction. six days We will use a single clinical laboratory to measure HbA1c values. The need of extraction will be evaluated using clinical and radiographic examinations. To minimize differences due to operator variability, all the extractions will be performed by the same oral surgeon using standard technique. All patients will undergo complete descaling and root planning one week before tooth extraction and perioperative plaque control. A preoperative oral rinse with a 12% chlorexidine mouthwash will be performed. Extractions will be done with single use gloves and masks using minimal sterile instrumentation including mucoperiosteal elevator, straight elevator and forceps. After complete tooth removal, the socket will be inspected, irrigated copiously. To make sure all patients will be evaluated; a single suture will be placed after extraction.Patients will be asked to follow up on the 7th post-operative day to get the suture removed and to evaluate pain, dry socket, Suppurated alveolitis and local signs of infection (abscess or cellulitis).All patients will be asked to report earlier than 7days if they developed any complications. If there will be any complications during tooth extraction, including use of excessive force, root fracture or a need for open surgery the patient will be excluded from the study. 60 Placebo
Experimental Group Single dose of antibiotic two gram of amoxicillin one hour prior to the extraction,no post-operative antibiotics prescription with one gram placebo taken 2 times a day for 6 days following the intervention. six days We will use a single clinical laboratory to measure HbA1c values. The need of extraction will be evaluated using clinical and radiographic examinations. To minimize differences due to operator variability, all the extractions will be performed by the same oral surgeon using standard technique. All patients will undergo complete descaling and root planning one week before tooth extraction and perioperative plaque control. A preoperative oral rinse with a 12% chlorexidine mouthwash will be performed. Extractions will be done with single use gloves and masks using minimal sterile instrumentation including mucoperiosteal elevator, straight elevator and forceps. After complete tooth removal, the socket will be inspected, irrigated copiously. To make sure all patients will be evaluated; a single suture will be placed after extraction.Patients will be asked to follow up on the 7th post-operative day to get the suture removed and to evaluate pain, dry socket, Suppurated alveolitis and local signs of infection (abscess or cellulitis).All patients will be asked to report earlier than 7days if they developed any complications. If there will be any complications during tooth extraction, including use of excessive force, root fracture or a need for open surgery the patient will be excluded from the study. 60
Experimental Group postoperative antibiotic Patients will receive a single dose of Placebo (one gram) one hour prior to the extraction and 1-gram of amoxicillin taken 2 times a day for 6 days following the dental extraction. six days We will use a single clinical laboratory to measure HbA1c values. The need of extraction will be evaluated using clinical and radiographic examinations. To minimize differences due to operator variability, all the extractions will be performed by the same oral surgeon using standard technique. All patients will undergo complete descaling and root planning one week before tooth extraction and perioperative plaque control. A preoperative oral rinse with a 12% chlorexidine mouthwash will be performed. Extractions will be done with single use gloves and masks using minimal sterile instrumentation including mucoperiosteal elevator, straight elevator and forceps. After complete tooth removal, the socket will be inspected, irrigated copiously. To make sure all patients will be evaluated; a single suture will be placed after extraction.Patients will be asked to follow up on the 7th post-operative day to get the suture removed and to evaluate pain, dry socket, Suppurated alveolitis and local signs of infection (abscess or cellulitis).All patients will be asked to report earlier than 7days if they developed any complications. If there will be any complications during tooth extraction, including use of excessive force, root fracture or a need for open surgery the patient will be excluded from the study. 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Male or female patients 18 years or older Patients with known history of insulin-dependent diabetes or noninsulin-dependent diabetes mellitus with glycosylated hemoglobin levels between 8% and 11% the previous two to three months. Extraction requiring minimal instrumentations. Surgical extraction procedure Immuno compromised patients or patient having diseases or conditions associated with impaired wound or osseous healing like: HIV,AIDS,hematologicalneoplasia, following transplant surgery,patient undergoing chemotherapy,patient under or with antecedents of antiresorptive drugs administration (bisphosphonate, denosumab),patient undergoing or with history of radiation in the maxillafacial region,patient under immunosupressive drugs: corticosteroids, thalidomide Patients undergoing extractions of endodontically treated teeth Patient currently taking antibiotics at the time of extraction or have had antibiotics less than 3days prior to extraction Patient with habits wich are known to be determinal to oral wound healing such as smoking, alcohool… Co-existing of local or systemic infection Pregnant and lacting patients Recent use of any anti-inflammatory drugs (used within one month previous) Allergy to drugs used in the study Patients taking antibiotics within 1 week after extraction for other infectious diseases. Having a dental emergency Having acute dental or periodontal infections requiring antibiotic prescription 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 29/09/2020 Committee for the Protection of Persons
Ethics Committee Address
Street address City Postal code Country
avicenne stree,Monastir 5000 Monastir 5000 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Occurrence of postoperative complication including: Dry socket: persistent pain and exposure of the alveolar bone. Suppurated alveolitis: which identified by provoked pain and alveolus filled; the clot becomes infected, covered by a grayish green membrane and it may consists of dental fragments or osseous sequestrum. Abscess: Localized bacterial infection, localized pain and swelling, it may present clinically as a fluctuant buccal or palatal swelling, with or without a draining fistula. Cellulitis: may follow tooth extraction if the infection spreads into the surrounding tissues. Diffuse, tense, painful swelling of the affected tissues occurs. Regional lymphadenopathy is common, and fever may be present. Patients will be asked to follow up on the 7th post-operative day and on the 14th post-operative day
Secondary Outcome Delayed wound healing: According to the literature, the dental alveolus is filled with blood clot and fibrin at 3 days after dental extraction; on postoperative day 7, the alveolus is filled with granulation tissue; on postoperative day 21, wound epithelialization is complete; and on postoperative day 60, alveolar bone formation can be observed on a dental radiographic image. Delayed wound healing was defined as a delay in any of the aforementioned events Patients will be asked to follow up on the 7th post-operative day and on the 14th post-operative day
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University Hospital Farhat Hached Bd Ibn El Jazzar 4002 Sousse Sousse 4000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Research Laboratory LR 12SP10 Functional and Aesthetic Rehabilitation of Maxillary Ibn El Jazzar street Sousse 4000 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Research Laboratory LR 12SP10 Functional and Aesthetic Rehabilitation of Maxillary Ibn El Jazzar street Sousse 4000 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Dhekra Jlassi Ibn Jazzar street Sousse 4000 Tunisia
Nour Saida Ben Messaoud Ibn Jazzar street Sousse 4000 Tunisia
Ghada Bouslama Ibn Jazzar street Sousse 4000 Tunisia
Rim Ghammem Ibn Jazzar street Sousse 4000 Tunisia
Aya Mtiri Ibn Jazzar street Sousse 4000 Tunisia
Souha Ben Youssef Ibn Jazzar street Sousse 4000 Tunisia
Abdellatif Boughzella Ibn Jazzar street Sousse 4000 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jlassi Dhekra jlassidhekra137@gmail.com +21654913985 Avicenne street
City Postal code Country Position/Affiliation
Monastir 5000 Tunisia Oral Surgery Unit Dental Medicine Department in University Hospital Farhat Hached
Role Name Email Phone Street address
Scientific Enquiries Ben Messaoud Nour Sayda drnoursaydabm@gmail.com +21629676406 Avicenne street
City Postal code Country Position/Affiliation
Monastir 5000 Tunisia Oral Surgery Unit Dental Medicine Department in University Hospital Farhat Hached
Role Name Email Phone Street address
Public Enquiries Boughzala Abdellatif bgzsousse@gmail.com +21697554064 Ibn El Jazzar street
City Postal code Country Position/Affiliation
Sousse 4000 Tunisia Oral Surgery Unit Dental Medicine Department in University Hospital Farhat Hached
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared. The Study Protocol, Statistical Analysis Plan, Informed and Consent form will be made available Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Six months after the end of the study Proposal should be directed to jlassidhekra137@gmail.com . To gain access, data requestors will need to sign a data access agreement.
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