NCT05712343

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started May 2023

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

May 25, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

January 25, 2023

Last Update Submit

July 11, 2023

Conditions

Severe Periodontitis

Outcome Measures

Primary Outcomes (3)

  • Clinical attachment level

    Clinical examinations, carried out at baseline and at 3-and 6-month post-baseline treatment, will include a whole-mouth measurement of clinical attachment loss level

    6 months

  • Periodontal pocket depth

    Clinical examinations, carried out at baseline and at 3-and 6-month post-baseline treatment, will include a whole-mouth measurement of periodontal probing depth

    6 months

  • gingival bleeding on probing

    Clinical examinations, carried out at baseline and at 3-and 6-month post-baseline treatment, will include a whole-mouth measurement of gingival bleeding on probing

    6 months

Study Arms (2)

valacyclovir group

EXPERIMENTAL

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).

Drug: Valacyclovir group

Control group

ACTIVE COMPARATOR

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

Other: Control group

Interventions

Valacyclovir groupDRUG

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

valacyclovir group
Control groupOTHER

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

Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Periodontitis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Mike Sabeti, DDS

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mike Sabeti, DDS

CONTACT

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

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 3, 2023

Study Start

May 25, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

July 12, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)