Application of thermosensitive hydroxybutyl chitosan hydrogel after third molar extraction
| ISRCTN | ISRCTN11664472 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11664472 |
- Submission date
- 23/10/2023
- Registration date
- 27/10/2023
- Last edited
- 29/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Impacted third molars are teeth at the back of the mouth that don't have enough room to emerge or develop normally. The extraction of impacted third molars is one of the most common operations in oral and maxillofacial surgery, and composite wound dressings with hydroxybutyl chitosan as the core have great prospects for application. The aim of this study is to assess the effect of a thermosensitive hydroxybutyl chitosan hydrogel on the postoperative reaction and quality of life of patients treated with impacted mandibular third molar extraction.
Who can participate？
Patients aged 18-35 years undergoing impacted mandibular (lower jaw) third molar extraction
What does the study involve?
Participants underwent impacted mandibular (lower jaw) third molar extraction and were randomly allocated to one of two groups. A thermosensitive hydroxybutyl chitosan hydrogel was used in the study group, and normal saline stored at the same temperature was used in the control group. Pain, facial swelling and mouth opening were evaluated on the first, third and seventh days after the operation. Quality of life and wound healing scores were evaluated on the third and seventh days after the operation.
What are the possible benefits and risks of participating?
There is almost no risk in this study and patients can withdraw at any time if they feel unwell during the study. The main risk is the risk of extraction of mandibular third molars, such as lower alveolar nerve injury and wound infection.
Where is the study run from?
First Affiliated Hospital of Anhui Medical University (China)
When is the study starting and how long is it expected to run for？
June 2022 to June 2023
Who is funding the study？
First Affiliated Hospital of Anhui Medical University (China)
Who is the main contact?
Min-gen Yang, 635550525@qq.com
Contact information
Public, Scientific, Principal Investigator
No.218 Jixi Road
Shushan District
Hefei City
230000
China
 ORCID ID |
0009-0005-4551-4931 |
|---|---|
| Phone | +86 (0)18879691806 |
| 635550525@qq.com |
Study information
| Study design | Single-center double-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life, Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Effect of thermosensitive hydroxybutyl chitosan hydrogel on postoperative reaction and quality of life after impacted mandibular third molar extraction: a split-mouth, randomized, double-blind, clinical trial |
| Study objectives | The original hypothesis was that there was no significant difference in the postoperative response or quality of life of patients after impacted mandibular third molar extraction treated with and without thermosensitive hydroxybutyl chitosan (ts-HBC) hydrogel. |
| Ethics approval(s) |
Approved 26/07/2023, First Affiliated Hospital of Anhui Medical University Committee On Medical Ethics (No.218 Jixi Road, Shushan District, Hefei City, 230000, China; +86 (0)551 6292 2017; 180003052@qq.com), ref: Quick-PJ 2023-09-50 |
| Health condition(s) or problem(s) studied | Impacted mandibular third molar extraction |
| Intervention | Participants were divided into experimental and control groups, the control group was given saline stored at the same temperature and the experimental group was given hydrogel. Randomization procedure: The two groups were preoperatively prepared using four sealed opaque envelopes; one pair to determine whether to use the hydrogel, and the other pair to determine whether to use the hydrogel on the left or right side. Before the operation, the patients were asked to extract an envelope from each of the two pairs, and the experimental group and the control group were determined according to the combined results. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Pain measured using the visual analogue scale (VAS) score on the first, third and seventh days after the operation 2. Swelling: distance from the outer canthus to the mandibular angle (I), the tragus to the mouth angle (II) and the tragus to the mandibular angle (III) measured using a tape measure, and the following formula was applied: (I + II + III)/3 (mm) at baseline and the first, third and seventh days after the operation 3. Mouth opening: distance between the tips of the upper and lower central incisors was measured using a Vernier calliper to evaluate the degree of mouth opening at baseline and the first, third and seventh days after the operation |
| Secondary outcome measures | 1. Quality of life measured using a questionnaire which included questions on social isolation, diet, sleep, appearance, and speech on the third and seventh days after the operation 2. Wound healing: the index reported was used to evaluate wound healing. The total score was 5 points, with higher scores indicating better healing, on the third and seventh days after the operation. |
| Overall study start date | 01/06/2022 |
| Completion date | 07/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 35 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Age 18-35 years 2. American Society of Anaesthesiologists (ASA) status 1-2 3. No seafood allergies 4. Pell, Gregory and Winter classification of class I, position B, and horizontal impaction, respectively 5. Good oral hygiene 6. No systemic diseases 7. Ability to cooperate in completing postoperative follow-up |
| Key exclusion criteria | 1. Contraindications to tooth extraction 2. Seafood allergy 3. Failure to follow the research protocol after the operation 4. Time difference between the two operations of more than 10 min 5. Periodontal disease or acute wisdom tooth pericoronitis with antibiotic use in the past week 6. Allergy to drugs used in the research process 7. Incomplete postoperative follow-up |
| Date of first enrolment | 01/06/2022 |
| Date of final enrolment | 31/05/2023 |
Locations
Countries of recruitment
- China
Study participating centre
Hefei City
230000
China
Sponsor information
Hospital/treatment centre
No.218 Jixi Road
Shushan District
Hefei City
230000
China
| Phone | +86 (0)18879691806 |
|---|---|
| 635550525@qq.com | |
| Website | http://www.ayfy.com/ |
"ROR" |
https://ror.org/03t1yn780 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Min-gen Yang (635550525@qq.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 29/04/2024 | No | No |
Additional files
Editorial Notes
29/04/2024: Basic results uploaded.
23/10/2023: Study's existence confirmed by the First Affiliated Hospital of Anhui Medical University.
