Recruiting
Early Phase 1

Valacyclovir

Sponsor:

UCLA

Code:

NCT05712343

Conditions

Severe Periodontitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Valacyclovir group

Control group

Study Details

Brief summary:

The experiment outlined in this proposal is designed to test the hypothesis that herpesvirus suppression by the systemic anti-herpesvirus valacyclovir (Valtrex) can significantly help to arrest the progressive course of severe marginal periodontitis in adult patients. A prospective, randomized, placebo-controlled, double-blind, clinical trial is employed to test this hypothesis.

Conditions

Severe Periodontitis

Study ID

NCT05712343

Start date

May 25, 2023

Status verified date

Jul, 2023

Completion date

Mar 1, 2024

Anticipated

Primary completion date

Mar 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients must be systemically healthy, Class I dental category.
  • Involved teeth must have periodontal disease detectible by periodontal examination.
  • Subjects with deep vertical periodontal lesions (>6 mm) showing no radiographic crestal alveolar lamina dura

Exclusion Criteria:

  • Presence of any disease or medication that alters the immune system or interferes with healing ability Smokers (more than 10 cigarettes per day)
  • External or internal tooth resorption
  • Tooth perforation from the pulp cavity through the tip of the root exposing the tissue to material in the oral cavity.
  • Pregnant or nursing mothers because hormonal factors may influence the condition.
  • Allergies or adverse reactions to valacyclovir.
  • Patients under the age of 18.
  • Patients with renal impairment or reduced renal function.
  • Patients requiring hemodialysis or peritoneal dialysis.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: valacyclovir group

Patients (N=20) in the valacyclovir group will be received, at baseline, periodontal scaling + valacyclovir (500 mg, 3 times a day for 3 days) ("Valacyclovir" group).

active comparator: Control group

Patients (N=20) in the control group will receive, at baseline, periodontal scaling + placebo medication, three times a day for 3 days ("Control" group).

Interventions

Valacyclovir group

The valacyclovir group will be received, valacyclovir (500 mg, 3 times a day for 3 days)

Control group

The control group will receive placebo medication, three times a day for 3 days.

Primary outcome measure

  • Clinical attachment level [ Time Frame: 6 months ]
  • Periodontal pocket depth [ Time Frame: 6 months ]
  • gingival bleeding on probing [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Mike Sabeti, DDS

415-476-0822mike.sabeti@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Principal Investigator:

Mike Sabeti, DDS

More Information

Sponsor

University of California, San Francisco

Last update posted

Jul 12, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2023-07-12.