Pain management after immediate implant placement
| ISRCTN | ISRCTN90549666 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90549666 |
| Sponsor | Changshu Yuhui Dental Hospital |
| Funder | Changshu Yuhui Dental Hospital |
- Submission date
- 21/07/2026
- Registration date
- 27/07/2026
- Last edited
- 24/07/2026
- 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 Shilei Han
Principal investigator, Public, Scientific
Principal investigator, Public, Scientific
No. 77, New Century Avenue
Changshu
215500
China
| Phone | +86 (0)18852905844 |
|---|---|
| han_shix43319@126.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | Application of liposomal bupivacaine in pain management after immediate implant placement |
| Study objectives | |
| Ethics approval(s) |
Approved 10/08/2025, Ethics Committee of Changshu Yuhui Dental Hospital (No. 77, New Century Avenue, Changshu, 215500, China; +86 (0)512 52179817; beesugara_fm@outlook.com), ref: No. 2025-Lunshen-002 |
| Health condition(s) or problem(s) studied | Postoperative pain management in patients undergoing immediate dental implant placement (≤3 implants) |
| Intervention | Participants were randomly assigned to an experimental group (n=16) and a control group (n=16) using a random number table. The specific steps for randomization and allocation concealment were as follows: 1. Random Sequence Generation: A research assistant (not involved in clinical procedures or evaluations) generated a random number sequence for patients numbered 1～32 using SPSS 22.0 software; 2. Allocation Concealment: Based on the random allocation sequence, group information (the experimental group or control group) was placed into sequentially numbered, sealed, and opaque envelopes (SNOSE method). These envelopes were kept by designated personnel to ensure that the clinical physicians, evaluators, and patients could not access group information before patient enrollment and signing of informed consent forms; 3. Implementation of Randomization: After enrollment, patients were numbered in the order of their inclusion. A surgical assistant sequentially opened the corresponding numbered envelope, assigned the patients to the experimental or control group following the instructions inside the envelope, and then notified the operating physician to execute the corresponding analgesic protocol. Experimental group: Routine articaine anaesthesia was implemented. After surgery, 3–5 ml of 1.3% liposomal bupivacaine was injected subperiosteally and around incisions: 3 ml for a single implant, 4–5 ml for 2–3 implants, with local compression for 1–2 min after injection. Control group: Only routine articaine anaesthesia was used without postoperative long-acting local anaesthetic. Surgical procedures were identical in the two groups. |
| Intervention type | Drug |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Liposomal bupivacaine |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 28/02/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 26 |
| Total final enrolment | 32 |
| Key inclusion criteria | 1. ≤3 immediate implants with intact socket bone wall 2. Aged 18–70 years, American Society of Anesthesiologists (ASA) I–II 3. No local anaesthetic or nonsteroidal anti-inflammatory drug (NSAID) allergy 4. Complete 72-h follow-up 5. Voluntary informed consent |
| Key exclusion criteria | 1. Women who are pregnant or lactating 2. Severe cardiopulmonary, hepatic or renal disease, coagulation disorders or uncontrolled diabetes (fasting blood glucose >8.0 mmol/l) 3. Combined bone grafting and sinus elevation 4. Long-term analgesic or hormone dependence 5. Patients with psychiatric disorders who are unable to cooperate 6. Acute or chronic inflammation of the surgical site |
| Date of first enrolment | 01/09/2025 |
| 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
21/07/2026: Study's existence confirmed by the Ethics Committee of Changshu Yuhui Dental Hospital.
