The Efficacy of Systemic Valacyclovir (Valtrex) on Periodontitis
NCT ID: NCT05712343
Last Updated: 2023-07-12
Study Results
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Basic Information
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UNKNOWN
EARLY_PHASE1
40 participants
INTERVENTIONAL
2023-05-25
2024-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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).
Valacyclovir group
The valacyclovir group will be received, valacyclovir (500 mg, 3 times a day for 3 days)
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).
Control group
The control group will receive placebo medication, three times a day for 3 days.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
Yes
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Mike Sabeti, DDS
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Mike Sabeti, DDS
Role: primary
Related Links
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Herpesviral-bacterial interactions in periodontal diseases
Herpesviruses in periodontal diseases
Other Identifiers
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22-36008
Identifier Type: -
Identifier Source: org_study_id
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