Clinical efficacy of acacia nilotica (Arabic gum) extract on prevention of dry socket after impacted lower third molar surgery: a randomized controlled trial
| ISRCTN | ISRCTN13917370 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13917370 |
- Submission date
- 12/04/2025
- Registration date
- 22/04/2025
- Last edited
- 22/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Surgical extraction of impacted teeth can be associated with multiple postoperative complications like pain, swelling, trismus (lockjaw), and alveolar osteitis (dry socket). Clinicians therefore have adopted various interventions over the years to minimize these postoperative complications with varying degrees of success. The aim of this study was to assess the effectiveness and safety of A. nilotica in controlling post-interventional complications (pain, inflammation, trismus, amount of analgesics required and overall wound healing) in patients undergoing surgical extraction of mandibular (jaw) third molars.
Who can participate?
Patients aged 18 years and over who attended dental clinics to extract mandibular third molars
What does the study involve?
Patients were randomly allocated to one of the two study groups. Group 1 subjects (test group) were given a 50% solution of Acacia nilotica mouthrinse while group 2 (control) were given a saline water mouthrinse (placebo). After surgical extraction, both groups were instructed to rinse with 10 ml of their designated mouthrinse twice a day for 7 days, with instructions to start using it after 24 hours for 60 seconds after toothbrushing. Wound healing, edema (swelling), trismus, and pain were evaluated after days 3 and 7.
What are the possible benefits and risks of participating?
The expected benefits of this study are to improve postoperative wound healing and by extension it may aid in the prevention of alveolar osteitis.
No harmful side effects are expected as gum acacia is used as a food additive and is considered Generally Recognized As Safe or GRAS under the Food and Drug Administration’s code of federal regulations. Gum acacia is permitted for use under the Good Manufacturing Practices in the United States, in the Middle East, Europe, and West Africa. The FDA agreed that acacia gum has physiological effects beneficial to human health, such as the reduction of blood glucose and insulin levels after it is eaten with a meal containing a carbohydrate that raises blood glucose levels.
Where is the study run from?
Dental Clinics of the College of Dentistry, King Khalid University (Saudi Arabia)
When is the study starting and how long is it expected to run for?
September 2023 to December 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Mashail Hamid, mhamid@kku.edu.sa
Contact information
Public, Scientific, Principal Investigator
Abha
Abha
61421
Saudi Arabia
 ORCID ID |
0000-0002-7743-1816 |
|---|---|
| Phone | +966 (0)555967705 |
| mhamid@kku.edu.sa |
Study information
| Study design | Single-center randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Dental clinic |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The efficacy of acacia nilotica extract on the prevention of alveolar osteitis after impacted lower third molar surgery: a randomized controlled trial |
| Study objectives | Acacia nilotica extract is effective in reducing post-operative complications in third molar surgery |
| Ethics approval(s) |
Approved 30/09/2023, The Research Ethics Committee, College of Dentistry, King Khalid University (King Khalid University, Abha, Abha, 61421, Saudi Arabia; +966 (0)172418005; src-cod@kku.edu.sa), ref: IRB/KKUCOD/ETH/2023-24/004 |
| Health condition(s) or problem(s) studied | Prevention of postoperative complications after extraction of impacted lower third molars |
| Intervention | Method of randomization: Systematic allocation was used (alternate allocation based on the patient’s presence at the dental clinic). Patients with impacted lower third molars with a moderate difficulty index were randomly allocated into one of the two study groups. Group 1 subjects (test group) were given a 50% solution of Acacia nilotica mouth rinse while group 2 (control) were given a saline water mouthrinse (placebo). After surgical extraction, both groups were instructed to rinse with 10 ml of their designated mouth rinse twice a day for 7 days, with instructions to start using it after 24 hours for 60 seconds after toothbrushing. Wound healing, edema, trismus, and pain were evaluated after days 3 and 7. |
| Intervention type | Other |
| Primary outcome measure | 1. Pain measured using a visual analog scale, ranging from 0 (“no pain”) to 10 (“unbearable pain”) at 9 pm for 7 consecutive days 2. Trismus evaluated using a Vernier gauge to measure the interincisal distance between the right upper and lower central incisors at day 1, 3 and 7 post-extraction 3. Extraoral swelling measured with a 3-0 silk suture put between tragus and corner of mouth, following the maximal convexity of the cheek, and measured against a ruler at day 1, 3 and 7 post-extraction 4. Wound healing evaluated by checking wound edges, color of mucosa and wound closure at day 7 post-intervention after suture removal |
| Secondary outcome measures | Signs of other postoperative complications, such as postoperative infection and pus discharge |
| Overall study start date | 30/09/2023 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 19 |
| Key inclusion criteria | 1. Adult patients (aged 18 years and above) 2. Referred to extract their impacted lower third molars with a moderate difficulty index (scores between 5 and 6) according to the Pederson scale |
| Key exclusion criteria | 1. History of sensitivity to Acacia Nilotica 2. Uncontrolled systemic diseases 3. History of malignancy or irradiation to the site of extraction 4. History of antibiotics, corticosteroids, anticoagulants, and contraceptive drugs use over the past month 5. Smokers 6. Pregnant or breastfeeding mothers 7. Uncontrolled infection at the site of extraction |
| Date of first enrolment | 01/10/2023 |
| Date of final enrolment | 24/12/2023 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
61421
Saudi Arabia
Sponsor information
Hospital/treatment centre
Abha
Abha
61421
Saudi Arabia
| Website | https://www.kku.edu.sa/en |
|---|---|
"ROR" |
https://ror.org/052kwzs30 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The dataset generated and/or analysed during the current study will be available upon request from Dr Mashail Hamid (mhamid@kku.edu.sa). |
Editorial Notes
22/04/2025: Study's existence confirmed by the Research Ethics Committee, College of Dentistry, King Khalid University.
