Effects of compound chamomile lidocaine gel after mandibular third molar surgeries

ISRCTN	ISRCTN42225408
DOI	https://doi.org/10.1186/ISRCTN42225408
Sponsor	Accademia di Belle Arti di Frosinone
Funder	Investigator initiated and funded

Submission date: 03/06/2026
Registration date: 19/06/2026
Last edited: 19/06/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Yang Wu
Principal investigator, Scientific

Department of Oral & Maxillofacial Surgery, School & Hospital of Stomatology, Wuhan University
Wuhan
430079
China

ORCID ID	0000-0002-4882-5584
Phone	+86 13720390002
Email	wuyang83@whu.edu.cn

Miss Meng-Di Nie
Public

State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, Key Laboratory of Oral Biomedicine Ministry of Education, Hubei Key Laboratory of Stomatology, School & Hospital of Stomatology, Wuhan University
Wuhan
430079
China

Phone	+86 18286842858
Email	xndm688@163.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Parallel
Purpose	Treatment
Scientific title	Effects of compound chamomile lidocaine gel after mandibular third molar surgeries: a double-blind randomised controlled trial
Study objectives
Ethics approval(s)	Approved 23/03/2026, The Ethics Committee of the School & Hospital of Stomatology, Wuhan University (No. 237, Luoyu Road, Hongshan District, Wuhan, 430079, China; +86 27-87686250; wdkqllwyh@163.com), ref: [WDKQ2026]伦审字（B27）号
Health condition(s) or problem(s) studied	Analgesic effect of compound chamomile lidocaine gel after third molar extraction
Intervention	The statistician uses EXCEL to generate a random sequence in advance, then writes each group result on separate slips of paper and places them in envelopes that are identical in appearance, opaque, and numbered in order. The envelopes are sealed and stored in consecutive numerical order. When a patient is enrolled, the researcher opens the next envelope in sequence and carries out the group assignment specified inside the envelope. The numbering must be consecutive and cannot be skipped. Envelopes can only be opened when a patient is enrolled and must not be opened prematurely. According to the randomization results, after surgery, the experimental group's extraction sockets are filled with compound chamomile lidocaine gel, then sutured and compressed for hemostasis, while the control group's extraction sockets are filled with a placebo, then sutured and compressed for hemostasis. Both groups are instructed to take oral ibuprofen as needed for pain after surgery, and the frequency of analgesic use is recorded. Follow up for 7 days.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Compound Chamomile Lidocaine Gel (Kamistad gel)
Primary outcome measure(s)	NRS Pain Score measured using NRS Pain Assessment Questionnaire at 2 hours, 6 hours, 12 hours after surgery, 1 day, 2 days, 3 days, 5 days, 7 days after surgery
Key secondary outcome measure(s)	Frequency and dosage of painkillers measured using Questionnaire at Within 7 days after surgery The degree of facial swelling measured using The tape measure method described by Gabka and Matsumara at The third day after surgery
Completion date	07/03/2026

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	50 Years
Sex	All
Target sample size at registration	37
Total final enrolment	37
Key inclusion criteria	1. Age range: 18-50 years 2.no mouth opening restrictions, no cardiovascular or pulmonary diseases, normal liver and kidney function, no history of abnormal bleeding or coagulation disorders, or other contraindications to tooth extraction 3.Based on the combination of the Winter classification and the Pell & Gregory classification, we included mandibular third molars of classes IA, IB, IIA, IIB vertical, and IIA mesioangular impactions. All types of wisdom teeth surgeries were completed within 30 minutes by experienced doctors after evaluating imaging and oral examinations 4. The patient is in good overall health, with no systemic diseases (ASA I/II) 5. Voluntarily participates in the study and completes the questionnaire, and has signed the informed consent form and committed to follow-up
Key exclusion criteria	1. Menstruating women, pregnant women, or breastfeeding women 2. Presence of systemic diseases, such as coagulation disorders, cardiovascular and cerebrovascular diseases, or endocrine diseases 3. Allergy to chamomile, lidocaine, or intraoperative use of artemisinin hydrochloride used in this study 4. History of taking any analgesics within the past week, or long-term medication use 5. Presence of untreated dental pain conditions, such as pulpitis, periodontitis with apical inflammation, or trigeminal neuralgia, requiring long-term analgesia 6. History of invasive dental treatment within the past week 7. Concurrent acute oral infection or tumor 8. Alcohol consumption within one week before surgery 9. Active or past history of digestive ulcers, gastrointestinal bleeding, or perforation; 10. Currently using ibuprofen, selective cyclooxygenase-2 (COX-2) inhibitors, or other non-steroidal anti-inflammatory drugs; 11. History of previous surgery.
Date of first enrolment	20/07/2024
Date of final enrolment	28/02/2026

Locations

Countries of recruitment

China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

04/06/2026: Trial's existence confirmed by The Ethics Committee of the School & Hospital of Stomatology, Wuhan University.