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Application of thermosensitive hydroxybutyl chitosan hydrogel after third molar extraction

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11664472
Enrollment
60
Registered
2023-10-27
Start date
2022-06-01
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impacted mandibular third molar extraction Oral Health

Interventions

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 procedur
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 en

Sponsors

First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

China

Contacts

Public ContactMingen Yang
635550525@qq.com+86 (0)18879691806

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 7, 2026