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The Efficacy of Systemic Valacyclovir (Valtrex) on Periodontitis

Primary Purpose

Severe Periodontitis

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Valacyclovir group
Control group
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Periodontitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of California, San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

valacyclovir group

Control group

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Full Information

First Posted
January 25, 2023
Last Updated
July 11, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT05712343
Brief Title
The Efficacy of Systemic Valacyclovir (Valtrex) on Periodontitis
Official Title
The Efficacy of Systemic Valacyclovir (Valtrex) to Arrest Further Progression of Severe Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study will be conducted as a double-blind, randomized, 6-month clinical trial to test the efficacy of systemic valacyclovir to prevent further progression of severe periodontitis. Subjects with at least 4 deep vertical periodontal lesions (> 4 mm loss of clinical attachment level) showing no radiographic crestal alveolar lamina dura will be randomly assigned to one of two treatment groups. 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). Patients (N=20) in the control group will be received, at baseline, periodontal scaling + placebo medication, three times a day for 3 days ("Control" group). All patients in both treatment groups will be evaluated for the status of their periodontal disease after 3 months by assessing clinical attachment level changes, periodontal pocket depth, and gingival bleeding on probing. Patients showing one or more periodontal site(s) with ongoing clinical attachment level loss of 2 mm or more will be exited from the study and receive conventional periodontal treatment such as systemic antibiotics or surgery. Patients demonstrating no additional clinical attachment level loss will remain in the study for another 3 months, after which a final assessment of the periodontal status will be performed as described above. All patients will then be referred for conventional periodontal treatment. Using a random number generator, patients will be assigned to a study group and given an undifferentiable, opaque Manila packet containing valacyclovir or placebo medication as well as written instructions. Oral hygiene instructions will be given to all subjects at baseline by a dental hygienist. Follow-up oral hygiene evaluation and instruction and dental plaque recording will be performed at 3- and 6-months post baseline treatment by a dental hygienist. Study patients will be provided with one 8 oz toothpaste (Regular Colgate) and a soft toothbrush (Oral-B Soft). Patients will need to sign informed consent before enrollment into the study. Patients are free to discontinue the study at any time for any or for no reason. A periodontist who is blinded to the baseline valacyclovir/placebo treatment will perform the clinical and radiographic diagnostic procedures. 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, periodontal pocket depth, plaque index and degree of gingivitis (bleeding on probing). Radiographic evaluation of alveolar bone level and appearance (presence or absence of radiographic crestal alveolar lamina dura) will be performed at baseline and at 6- month post-treatment. The Mann-Whitney statistical tests will assess the outcome data. A manageable patient sample size of 40 is estimated to detect, with a power of 80% and a type I error of 0.05, a difference in periodontal outcome between the valacyclovir and the placebo group. A statistician will analyze the data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
valacyclovir group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients (N=20) in the control group will receive, at baseline, periodontal scaling + placebo medication, three times a day for 3 days ("Control" group).
Intervention Type
Drug
Intervention Name(s)
Valacyclovir group
Intervention Description
The valacyclovir group will be received, valacyclovir (500 mg, 3 times a day for 3 days)
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
The control group will receive placebo medication, three times a day for 3 days.
Primary Outcome Measure Information:
Title
Clinical attachment level
Description
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
Time Frame
6 months
Title
Periodontal pocket depth
Description
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
Time Frame
6 months
Title
gingival bleeding on probing
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mike Sabeti, DDS
Phone
415-476-0822
Email
mike.sabeti@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Sabeti, DDS
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mike Sabeti, DDS
First Name & Middle Initial & Last Name & Degree
Mike Sabeti, DDS

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/20017799/
Description
Herpesviral-bacterial interactions in periodontal diseases
URL
https://pubmed.ncbi.nlm.nih.gov/15853936/
Description
Herpesviruses in periodontal diseases

Learn more about this trial

The Efficacy of Systemic Valacyclovir (Valtrex) on Periodontitis

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