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.: PACTR202407576478340 Date of Approval: 30/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect Of Intra-Socket Application of Hyaluronic Acid Gel on Soft and Hard Tissue Healing Following Impacted Mandibular Third Molars Extraction
Official scientific title Effect Of Intra-Socket Application of Hyaluronic Acid Gel on Soft and Hard Tissue Healing Following Impacted Mandibular Third Molars Extraction: A randomized controlled trial
Brief summary describing the background and objectives of the trial One of the most frequent dental surgical procedures is the surgical extraction of an impacted 3rd molar. Surgical extraction of impacted 3rd molar results in post-operative pain, inflammation over the next 24 to 72 hours, and trismus, all of which cause significant patient discomfort. Also, the lower second molar's periodontal health is affected by the extraction of third molars. Periodontal disease affects second molars at a rate of 77% before surgery and 23% after . Furthermore, the type of surgical wound healing and regeneration is closely related to pain . and inflammation following surgery . Successful soft tissue healing depends on the coordinated interaction of a range of different tissues and cell types. Several systemic drugs, preservative materials, natural items, and irrigation techniques were used to reduce these complications and speed healing. Hyaluronic acid (HA) has a number of clinical applications in current practice because it participates in numerous biological processes related to morphogenesis and tissue healing. It has been discovered that HA significantly contributes to the acceleration of soft tissue healing by encouraging the creation of early granulation tissue, supporting re-epithelialization and angiogenesis and preventing damaging and inflammation. Additionally, hyaluronic acid seems to be efficient in reducing post-operative swelling & inflammation. Furthermore, it is essential for bone regeneration since it promotes the proliferation, adhesion, and movement of undifferentiated mesenchymal cells into osteoblastic cells. The aim of this study is to evaluate the effect of the intra-socket application of 0.8% hyaluronic acid (HA) gel on soft tissue healing and bone tissue healing following removal of impacted mandibular third molar.
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 01/02/2023
Actual trial start date 01/02/2023
Anticipated date of last follow up 01/08/2024
Actual Last follow-up date 01/08/2024
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Completed
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hyaluronic acid 1 ml of 0.8% of hyaluronic acid gel. Once at the start of the intervention Sterile disposable plastic needle used for injection of 0.5 ml of 0.8% of hyaluronic acid gel applied in the socket after removal of impacted mandibular third molar. Another 0.5 ml of 0.8% of hyaluronic acid gel applied after suturing. 15
Control Group Conventional group N/A at the start of the intervention Simple interrupted sutures for wound closure after extract of the impacted third molar 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with impacted mandibular third molar - Patients complaining from diseases that affect bone healing - Patients with bleeding problems, - Patients who have acute infection at the surgical side or purulent discharge. - Heavy Smoking - Alcoholic patients. - Pregnant women or whom use hormonal contraceptives or corticosteroids. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 20 Year(s) 40 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 22/01/2023 Institutional Review Boards IRB at the Faculty of Dentistry Alexandria University IRB NO 0595012023 International Number 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 Soft tissue healing After-extraction: day-three, day-seven and day-fourteen
Secondary Outcome Bone density Immediate, and 60 Days After Surgery,
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic in Oral and Maxillofacial Surgery Department in Faculty of Dentistry Alexandria university Champollion Street Alexandria University Faculty of Dentistry Azaritya Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Omnia Saad Mohamed elkady Oral and Maxillofacial Department Faculty of Dentistry Alexandria University, Champolion St., Azarita Alexandria 21521 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oral and Maxillofacial Department Faculty of Dentistry Alexandria University Champolion St., Azarita Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ossama Abbass Sweedan Oral and Maxillofacial Department Faculty of Dentistry Alexandria University, Champolion St., Azarita Alexandria 21521 Egypt
Tasneem Ahmed Amer Oral and Maxillofacial Department Faculty of Dentistry Alexandria University, Champolion St., Azarita Alexandria 21521 Egypt
Omnia Saad Mohamed elkady Oral and Maxillofacial Department Faculty of Dentistry Alexandria University, Champolion St., Azarita Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ossama Sweedan drossamasweedan@gmail.com 00201001506466 Oral and Maxillofacial Department Faculty of Dentistry Alexandria University, Champolion St., Azarita
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Oral and Maxillofacial Surgery Faculty of Dentistry Alexandria University Egypt
Role Name Email Phone Street address
Principal Investigator Tasneem Amer tasnim.amer@alexu.edu.eg 00201002992193 Oral and Maxillofacial Department Faculty of Dentistry Alexandria University, Champolion St., Azarita
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Assistant Professor of Oral and Maxillofacial Surgery Faculty of Dentistry Alexandria University Egypt
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
Role Name Email Phone Street address
Scientific Enquiries Omnia Elkady omnia.mohamed.dent@alexu.edu.eg 00201125222016 Oral and Maxillofacial Department Faculty of Dentistry Alexandria University, Champolion St., Azarita
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Master Degree Student at Oral and Maxillofacial Surgery Faculty of Dentistry Alexandria University Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual data will be available (including data dictionaries) All of the individual participant data collected during the trial, after de-identification. Study protocol and informed consent form will be available Data will be available: - Immediately following publication with no end date. - For anyone who wishes to access the data - For any type (purpose) of analyses - Upon proposal(s) that should be directed to elsayedamr@yahoo.com Informed Consent Form,Study Protocol Immediately following publication. No end date. Proposals should be directed to elsayedamr@yahoo.com 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