The effect of chamomile on healing and complications after tooth removal.
| ISRCTN | ISRCTN66356446 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66356446 |
| Secondary identifying numbers | 3126 |
- Submission date
- 16/02/2022
- Registration date
- 04/04/2022
- Last edited
- 01/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
This study aims to evaluate the application of chamomile on healing and complications after surgical extraction of impacted lower third molars.
Sometimes a wisdom tooth becomes stuck below the surface of your gums (impacted), and grows at an odd angle, possibly causing complications. Impacted wisdom teeth are third molars at the back of the mouth that don't have enough room to emerge or develop normally.
Who can participate?
Healthy adults aged 18 – 28 years who underwent surgical extraction of bilateral impacted lower third molars
What does the study involve?
Two impacted lower third molars will be extracted surgically for each patient. One will be filled with chamomile gel, the other with placebo gel. The visual analogue scales (VAS) scores, facial swelling, mouth opening, and soft tissue healing will be assessed over 7 days.
What are the possible benefits and risks of participating?
It is crucial for maxillofacial surgeons to decrease the post-extraction complications and improve the third molar extraction socket healing by using a simple method. Both gels are safe and should not cause any additional risks. All participants will receive the same treatment.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
September 2020 to April 2023
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Mohammed Qassem Abo Rokbah, aborokbahmohammed94@gmail.com
Contact information
Scientific
Al zahira
Damascus
-
Syria
 ORCID ID |
0000-0001-7201-1284 |
|---|---|
| Phone | +963 957590786 |
| mohammed8.aborokbah@damascusuniversity.edu.sy |
Study information
| Study design | Split-mouth interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 41180 PIS.pdf |
| Scientific title | Evaluation of the effect of topical application of chamomile after surgical extraction of impacted lower third molars: a clinical study |
| Study hypothesis | We are trying to test the efficacy of topical application of chamomile on healing and complications after impacted lower third molars surgical extraction. |
| Ethics approval(s) | Approved 07/09/2020, Damascus University Rector (Baramkeh, Damascus, Syria; +966 555063806;no email provided), ref:2948/SM |
| Condition | Pain, swelling and healing following surgical extraction of symmetrical impacted lower third molars |
| Intervention | This study is a split mouth randomized clinical trial. Both chamomile gel and placebo gel were colored red and loaded in coded syringes ("A" and "B") in equal quantities (2 ml), the researcher and the patients don't know which one is chamomile. Triangle full thickness flap was reflected and necessary bone removal was performed by slow speed straight surgical headpiece with continuous irrigation of saline solution. After the impacted molar was removed and the socket was well rinsed with saline. A randomized clinical trial was conducted, with one extraction socket being filled with chamomile gel and the other extraction socket being filed with placebo gel ("A" and "B") in the same patient. Patients returned after 1 week to have the sutures removed. They were followed up at 3 and 7 days. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | At 3 and 7 days. 1. Pain measured using visual analogue scales (VAS) 2. Facial swelling (clinical evaluation) 3. Mouth opening (clinical evaluation) 4. Soft tissue healing (clinical evaluation) |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 07/09/2020 |
| Overall study end date | 01/04/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 28 Years |
| Sex | Both |
| Target number of participants | 20 |
| Participant inclusion criteria | 1. Age 18-28 years 2. Indication for surgical extraction of impacted lower third molars in a symmetrical position according to the classification of Pell & Gregory 3. Good general health and there are no uncontrolled systemic diseases 4. Good oral health 5. No previous pain 6. No allergy or contraindication to the required postoperative prescription or to the Plants of Asteraceae/compositae family |
| Participant exclusion criteria | 1. Pregnancy or current menstraution 2. Uncontrolled diabetes, uncontrolled hypertension, neoplasms, known neuropsychiatric illness, blood dyscrasia, coagulation disorders, or metabolic disorders 3. Compromised immune system or other systemic diseases 4. Patients with pericoronitis, infection, pathological condition in the region of surgery |
| Recruitment start date | 11/01/2021 |
| Recruitment end date | 30/03/2022 |
Locations
Countries of recruitment
- Syria
Study participating centre
Mazzah High Way
Damascus
0096311
Syria
Sponsor information
University/education
Mazzeh highway
Damascus
-
Syria
| Phone | +963 1133923192 |
|---|---|
| info@damascusuniversity.edu.sy | |
| Website | http://damasuniv.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 01/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | After finishing the follow up procedure and writing the article, I am planning to publish it (with all results, statistical analysis and some photos) in Damascus University's journal, and many other international journals. |
| IPD sharing plan | Available on request (aborokbahmohammed94@gmail.com) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | in Arabic | 04/04/2022 | No | Yes | |
| Protocol file | 04/04/2022 | No | No |
Additional files
- 41180 Protocol.pdf
- 41180 PIS.pdf
- in Arabic
Editorial Notes
01/02/2023: Internal review.
04/04/2022: Trial's existence confirmed by Damascus University
