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Role of Herpesviruses as a Causative Factor in Acute Apical Abscess

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The Virus in Endodontics (VE) phase I pilot study for preoperative pain will be analyzed and adjusted for the Phase II clinical trial. The Phase II clinical trial on preoperative pain, postoperative pain, and clinical healing will involve 250 patients. Patients will be recruited from the same pool of participants as the Phase II clinical trial. Preoperative cone beam computed tomography (CBCT) scans will be taken as well as three and six month postoperative CBCT scans. The secondary outcomes form the Phase II randomized clinical trial will be clinical success and visible radiographic healing determined by CBCT images.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• Patient must be ≥ 18-year-old

• Patient must be systemically healthy; American Society of Anesthesiologists (ASA) Class I or II

• Patient must exhibit clinical evidence of pulp necrosis and acute apical abscess

• Patient must present with radiographic

• signs of apical disease either by

• periapical radiography or cone-beam

• computed tomography

• Patient consented to receive conventional pulpal debridement, incision and drainage at the end of the study

• Persistent pain of moderate or higher level (\>4) was the main inclusion criterion. Pain assessed as follows: 0 defined as no pain, 1-3 as mild pain, 4-6 as moderate pain, and 7-10 as severe pain

Locations
United States
California
UCSF Dental
RECRUITING
San Francisco
Contact Information
Primary
Mike Sabeti, DDS
Mike.Sabeti@ucsf.edu
415-476-0822
Time Frame
Start Date: 2023-10-25
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 60
Treatments
Experimental: valacyclovir group
250 patients presenting with pain and a diagnosis of acute apical abscess will be recruited for the VEII preoperative pain and VEIII postoperative pain and clinical/radiographic healing phases of the clinical trial.
Placebo_comparator: Control group
250 patients presenting with pain and a diagnosis of acute apical abscess will be recruited for the VEII preoperative pain and VEIII postoperative pain and clinical/radiographic healing phases of the clinical trial.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov