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Contribution of an antiviral drug (Valaciclovir) in the treatment of generalized periodontitis (stage III or IV and grade A, B or C): prospective, randomized and double blind clinical trial.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501957-35-00
Acronym
20-API-02
Enrollment
142
Registered
2023-05-26
Start date
2023-12-12
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized periodontitis (stage III or IV and grade A, B or C)

Brief summary

Efficacy will be assessed by measuring the periodontal bag depth at counding, unisng a graduated (in millimeter) and coloured probe used at low pressure (<0.2N) at visit 3

Detailed description

Conventional periodontal clinical indices are the Bleeding on Probing (BOP), the plaque index (PI), the Clinical Attachement Level (CAL) and the pocket depth at sounding. These indices will be collected from the same tooth that was determined for the primary objective, The EBV, CMV and HSV1 viruses levels in periodontal sample is measured through quantitative PCR of their viral genomes (DNA)., The twenty bacterial species level in periodontal sample is measured through quantitative PCR of the bacterial genomes (DNA)., Surgery is available from visit 3 (during periodontal re-evaluation) and is indicated for patient with a good degree of hygiene (IP≤ 20%) but with persistent pockets (PPS > 5mm) and bleeding at sounding., The oral health impact on quality of life score is based on the Oral Health Impact Profile 14 (OHIP-14) questionnaire, which measures the impact of oral conditions on the well-being and quality of life of the patient., The medico-economic impact is evaluated by the incremental cost-effectiveness ratio by relating the difference in the cost of each strategy to the difference in efficiency (number of patients who had therapeutic surgery during the follow-up period).

Interventions

DRUGValaciclovir Mylan 500 mg
DRUGfilmomhulde tabletten
DRUGCELLULOSE

Sponsors

Centre Hospitalier Universitaire De Nice
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Efficacy will be assessed by measuring the periodontal bag depth at counding, unisng a graduated (in millimeter) and coloured probe used at low pressure (<0.2N) at visit 3

Secondary

MeasureTime frame
Conventional periodontal clinical indices are the Bleeding on Probing (BOP), the plaque index (PI), the Clinical Attachement Level (CAL) and the pocket depth at sounding. These indices will be collected from the same tooth that was determined for the primary objective, The EBV, CMV and HSV1 viruses levels in periodontal sample is measured through quantitative PCR of their viral genomes (DNA)., The twenty bacterial species level in periodontal sample is measured through quantitative PCR of the bacterial genomes (DNA)., Surgery is available from visit 3 (during periodontal re-evaluation) and is indicated for patient with a good degree of hygiene (IP≤ 20%) but with persistent pockets (PPS > 5mm) and bleeding at sounding., The oral health impact on quality of life score is based on the Oral Health Impact Profile 14 (OHIP-14) questionnaire, which measures the impact of oral conditions on the well-being and quality of life of the patient., The medico-economic impact is evaluated by the incre

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026