Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05712343
Status:
RECRUITING
Last Update Posted:
2023-07-12
First Post:
2023-01-25
Brief Title:
The Efficacy of Systemic Valacyclovir Valtrex on Periodontitis
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
The Efficacy of Systemic Valacyclovir Valtrex to Arrest Further Progression of Severe Periodontitis
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 N20 in the valacyclovir group will be received at baseline periodontal scaling valacyclovir 500 mg 3 times a day for 3 days Valacyclovir group
Patients N20 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 sites 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 valacyclovirplacebo 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 005 a difference in periodontal outcome between the valacyclovir and the placebo group A statistician will analyze the data
Patients N20 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 sites 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 valacyclovirplacebo 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 005 a difference in periodontal outcome between the valacyclovir and the placebo group A statistician will analyze the data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None