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.: PACTR202210505141593 Date of Approval: 19/10/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title POSTOPERATIVE SEQUELAE AND QUALITY OF LIFE FOLLOWING IMPACTED MANDIBULAR THIRD MOLAR EXTRACTION - COMPLETE CLOSURE VERSUS SUTURELESS TECHNIQUE
Official scientific title POSTOPERATIVE SEQUELAE AND QUALITY OF LIFE FOLLOWING IMPACTED MANDIBULAR THIRD MOLAR EXTRACTION - COMPLETE CLOSURE VERSUS SUTURELESS TECHNIQUE
Brief summary describing the background and objectives of the trial The Sutureless technique is a relatively new practice of nonclosure of flap after an impacted wisdom tooth removal. Compared to the complete closure of flap, the sutureless technique is hypothesized to have less severity of inflammatory sequelae that characterizes the few days after a surgical extraction. The lesser inflammatory sequelae is believed to also have an improved quality of life in the sutureless group
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 17/12/2019
Actual trial start date 17/12/2019
Anticipated date of last follow up 05/11/2020
Actual Last follow-up date 05/11/2020
Anticipated target sample size (number of participants) 65
Actual target sample size (number of participants) 74
Recruitment status Completed
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Sutureless non closure. no stitches placed one week this is a newer practice for impacted wisdom teeth extraction. Upon raising a 3-sided mucoperiosteal flap and completion of tooth extraction, the flap is simply repositioned without placement of suturesl. the oral mucosa wound is expected to heal by secondary intention. 36
Control Group complete closure 3 or more stitches one week this is the standard technique used. Upon raising a 3-sided mucoperiosteal flap and complation of tooth extraction, the flap is repositioned and multiple stitches placed to ensure a hermetic seal. the oral mucosa wound is expected to heal by primary intention 38 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. ASA I patients at least age 18years with an indication for extraction of an impacted MTM under local anaesthesia. 2. Patients with mesioangular, distoangular, horizontal and vertical impactions with a difficulty index of 3–8, according to Pederson’s criteria. 1. Patients who do not provide informed consent 2. Patients with difficulty index greater than 8 according to Pederson criteria 3. Patients for M3 surgery not requiring a full thickness mucoperiosteal flap or bone removal. 4. Presence of symptoms such as severe pain, facial swelling or limited mouth opening from any cause within 10 days preceding surgery. 5. Patients who have allergy or cannot tolerate the local anaesthetic agent, and the study drugs. This includes patients with peptic ulcer disease. 6. Patients on medications that could interfere with healing after surgery – steroids, oral contraceptives, other anti-inflammatory drugs for other reasons 7. Patients who are uncooperative and anxious Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 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 05/11/2018 Health Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Usmanu DanFodiyo University Teaching Hospital Sokoto Sokoto PMB 2370 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative pain, swelling, trismus and quality of life one week
Secondary Outcome rate of complications one week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Usmanu Danfodiyo University Teaching Hospital Wamako, Sokoto Sokoto Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
CHUKWUMA Benedict Chimezie 25, Minfa Street, Trademore estate, Lugbe FCT Abuja Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self same as above FCT Abuja Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Abdurrazaq Taiwo Dental and Maxillofacial Surgery department, Usmanu Danfodiyo University Teaching hospital Sokoto Nigeria
Adebayo Ibikunle Dental and Maxillofacial Surgery department, Usmanu Danfodiyo University Teaching hospital Sokoto Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Benedict Chukwuma chukwumabenet@gmail.com +15874355590 25, Minfa street, Trademore estate, Lugbe
City Postal code Country Position/Affiliation
Abuja Nigeria Senior registrar Oral and maxillofacial surgery
Role Name Email Phone Street address
Scientific Enquiries Abdurrazaq Taiwo draotaiwo@gmail.com +2348078061517 Dental department, Usmanu Danfodiyo University Teaching Hospital
City Postal code Country Position/Affiliation
Sokoto Nigeria Head of Department
Role Name Email Phone Street address
Public Enquiries Ibikunle Adebayo adebayoibikunl@gmail.com +2348029190888 Dental department, Usmanu Danfodiyo University Teaching Hospital
City Postal code Country Position/Affiliation
Sokoto Nigeria Chief Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Available for a period of 2years who may request access - Open type of data analysis permitted - Quantitative data analysis who will decide - third party criteria for reviewing requests - qualifications
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 12/06/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 12/06/2022 Result - 12/06/2022 Result - 12/06/2022 Result - 12/06/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information