Effect of Subperiosteal Ropivacaine After Third Molar Extraction

NCT07844824 | Completed Phase 4

• 1 other identifier: 05-PA-30-XXIX-9/2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study examined whether an additional injection of the long-acting local anesthetic ropivacaine at the surgical site could reduce pain and improve recovery after removal of lower wisdom teeth. Adults aged 18 to 65 years who needed both lower wisdom teeth removed could take part. Each participant underwent two separate wisdom tooth removal procedures, approximately two weeks apart. After one procedure, ropivacaine was injected near the surgical area, while after the other procedure, a sterile saline solution was given in the same way for comparison. Neither the participant nor the surgeon knew which treatment was used at each procedure. Participants recorded their pain after surgery and their use of pain-relieving medication. Mouth opening and the effect of the procedure on daily life and oral health-related quality of life were also assessed. The purpose of the study was to determine whether adding ropivacaine at the surgical site could provide better pain relief and postoperative recovery than standard treatment alone.

Conditions

Wisdom Tooth Removal; Dental Anesthesia; Ropivacaine

Keywords

Ropivacaine; Dental anaesthesia; Third molar removal; Third molar extraction; Supplementary anesthesia

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity as Assessed by the Visual Analogue Scale (VAS) During the First 72 Hours After Surgery

  Participants recorded postoperative pain intensity using a Visual Analogue Scale (VAS) following each mandibular third molar extraction. Pain intensity was recorded separately after the ropivacaine-treated and placebo-treated procedures.

  2, 4, 6, 12, 24, 48, and 72 hours after surgery

Secondary Outcomes (4)

• Postoperative Maximal Interincisal Opening as Assessed Using the TheraBite Range of Motion Scale

  Postoperative days 1, 2, and 3

• Time to First Postoperative Rescue Analgesic Intake

  From completion of surgery until first rescue analgesic intake, assessed up to 72 hours after surgery.

• Postoperative Rescue Analgesic Consumption

  Day of surgery and postoperative days 1, 2, and 3

• Oral Health-Related Quality of Life as Assessed by the Oral Health Impact Profile-14 (OHIP-14)

  Postoperative day 7

Study Arms (2)

Ropivacaine-treated site

EXPERIMENTAL

Following surgical extraction and suturing of the mandibular third molar, the assigned surgical site received a supplementary subperiosteal injection of 2 mL of 0.75% ropivacaine at the buccal aspect of the extraction site.

Drug: Ropivacaine 0.75%

Placebo-treated site

PLACEBO COMPARATOR

Following surgical extraction and suturing of the mandibular third molar, the assigned surgical site received a supplementary subperiosteal injection of 2 mL of 0.9% sterile saline at the buccal aspect of the extraction site.

Other: Saline (0.9% NaCl)

Interventions

Ropivacaine 0.75% DRUG

Following surgical extraction and suturing of the mandibular third molar, 2 mL of 0.75% ropivacaine was administered as a supplementary subperiosteal injection at the buccal aspect of the extraction site, slightly apical to the bony socket.

Ropivacaine-treated site

Saline (0.9% NaCl) OTHER

Following surgical extraction and suturing of the mandibular third molar, 2 mL of 0.9% sterile saline was administered as a supplementary subperiosteal injection at the buccal aspect of the extraction site, slightly apical to the bony socket.

Placebo-treated site

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 65 years.
• American Society of Anesthesiologists (ASA) physical status I.
• Presence of both mandibular third molars, with both teeth indicated for surgical extraction.
• Both mandibular third molars of the same Pell and Gregory classification.
• Satisfactory dental and oral health, without acute inflammatory processes at the surgical site or elsewhere in the oral cavity, including pericoronitis, pulpitis, or apical periodontitis.
• No use of analgesic medication within 24 hours before surgery.
• No use of antibiotics within 1 month before surgery.
• Ability and willingness to provide written informed consent.
• Willingness and ability to comply with study procedures and follow-up.

You may not qualify if:

• American Society of Anesthesiologists (ASA) physical status II, III, or IV.
• Pregnancy or breastfeeding.
• Known allergy to amide-type local anesthetics, vasoconstrictors, or related compounds.
• Use of dietary supplements that could affect local anesthesia.
• History of drug or analgesic abuse.
• Unsatisfactory dental or oral health, including untreated dental caries, periodontitis, or periapical lesions.

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

Stomatološka poliklinika Zagreb

Zagreb, 10000, Croatia

Location

Related Publications (4)

• Steverink JG, Oostinga D, van Tol FR, van Rijen MHP, Mackaaij C, Verlinde-Schellekens SAMW, Oosterman BJ, Van Wijck AJM, Roeling TAP, Verlaan JJ. Sensory Innervation of Human Bone: An Immunohistochemical Study to Further Understand Bone Pain. J Pain. 2021 Nov;22(11):1385-1395. doi: 10.1016/j.jpain.2021.04.006. Epub 2021 May 5.

  PMID: 33964414 BACKGROUND

• Feldman HS, Covino BG. Comparative motor-blocking effects of bupivacaine and ropivacaine, a new amino amide local anesthetic, in the rat and dog. Anesth Analg. 1988 Nov;67(11):1047-52.

  PMID: 3189893 BACKGROUND

• Amorim KS, Gercina AC, Ramiro FMS, Medeiros LA, de Araujo JSM, Groppo FC, Souza LMA. Can local anesthesia with ropivacaine provide postoperative analgesia in extraction of impacted mandibular third molars? A randomized clinical trial. Oral Surg Oral Med Oral Pathol Oral Radiol. 2021 May;131(5):512-518. doi: 10.1016/j.oooo.2020.09.010. Epub 2020 Sep 30.

  PMID: 33223455 BACKGROUND

• Wang Y, Zhou A. A new improvement: subperiosteal cocktail application to effectively reduce pain and blood loss after total knee arthroplasty. J Orthop Surg Res. 2020 Jan 30;15(1):33. doi: 10.1186/s13018-020-1563-5.

  PMID: 32000816 BACKGROUND

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Davor Brajdic, DMD, PhD

  School of Dental Medicine Zagreb, University of Zagreb

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Dental Medicine, PhD Candidate

Model Details: Each participant underwent two mandibular third molar extraction procedures approximately two weeks apart and received both study interventions. One surgical site was randomly assigned to receive supplementary subperiosteal 0.75% ropivacaine, while the contralateral site received 0.9% sterile saline. The side receiving ropivacaine at the first procedure was randomized, and the alternate intervention was administered at the second procedure. As such, each participant served as their own control.

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 28, 2026
• Study Start: October 2, 2023
• Primary Completion: August 26, 2024
• Study Completion: August 26, 2024
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Access Criteria: De-identified individual participant data will be made available to qualified researchers conducting systematic reviews, meta-analyses, or other evidence-synthesis projects relevant to the study topic. Requests should include a brief research proposal describing the review question, planned analyses, and the data required. Requests will be reviewed by the study investigators to assess scientific relevance, methodological appropriateness, and consistency with the original informed consent and applicable data protection requirements. Approved requestors may be required to sign a data-sharing agreement specifying the permitted use of the data, data security requirements, and restrictions on further sharing.

Locations

CR (1)