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
- Conditions
- Periodontitis Chronic Generalized Severe
- Interventions
- Drug: Antiviral treatment with conventional non-surgical treatmentDrug: Placebo with conventional non-surgical treatment
- Registration Number
- NCT05902208
- Lead Sponsor
- Centre Hospitalier Universitaire de Nice
- Brief Summary
Periodontitis is an inflammatory pathology that destroys periodontitis and causes tooth loosening. Its high incidence, combined with very high oral and systemic morbidity, places this pathology at the heart of global public health priorities. The current therapeutic management of periodontitis is not satisfactory because it often leads to a stabilization of the disease, marked by frequent recurrences, especially severe forms. Improving the treatment of patients with periodontitis is therefore an essential priority.
If gingival bacterial dysbiosis is a major contributing factor, this model has clinical-biological limitations that suggest that other etiological factors are involved, and worsen the pathology. In particular, the literature provides clear evidence that periodontal lesions are mostly infected with Herpes EBV, CMV and HSV-1 viruses and that periodontal infection with these viruses is very directly correlated with disease progression (severity). In addition, our work provides new cellular and molecular data that demonstrate mechanisms of active EBV infection of cells and periodontal structures, and highlight inflammatory and necrotic effects associated with this infection. Given these observations and the high pathogenicity of herpes viruses, all known to be powerful inflammatory, lytic and immunomodulatory agents, it seems difficult not to evoke a direct etiopathogenic role of these viruses capable of acting synergistically with periodontopathogenic bacteria.
In this context, the use of an antiviral appears as a very attractive therapeutic proposal to effectively treat periodontitis in combination with conventional treatments. This original and innovative proposal can also be easily and quickly validated in a randomized therapeutic trial through the availability of antiviral molecules that are non-toxic and very specific to human herpes viruses that are derivatives of aciclovir.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 142
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Valaciclovir Antiviral treatment with conventional non-surgical treatment - Placebo Placebo with conventional non-surgical treatment -
- Primary Outcome Measures
Name Time Method Compare the efficacy of antiviral treatment (valaciclovir) with conventional non-surgical treatment (scaling and root planing) to conventional treatment with a placebo for generalized periodontitis (stage III or IV and grade A, B or C) 28 days after the end of antiviral treatment and 2 months after root surfacing Efficacy will be assessed by measuring the periodontal pocket depth using a graduated (in millimeter) and coloured probe used at low pressure (\<0.2N) 28 days after the end of antiviral treatment (visit 2) and 2 months after scaling and root planing (visit 3), during the periodontal reassessment visit
- Secondary Outcome Measures
Name Time Method Compare the efficacy of valaciclovir associated with conventional treatment to conventional treatment with placebo in the management of generalized periodontitis using a conventional periodontal clinical index, the Bleeding on Probing (BOP). 6 and 8 months after scaling and root planing The Bleeding on Probing (BOP) assesses the gingival inflammation based on gum bleeding after periodontal probing. It corresponds to the number of sites with bleeding divided by the total number of measured sites, expressed as a percentage. This index will be collected from the same tooth that was determined for the primary objective.
Compare changes in the CytoMegaloVirus (CMV) levels between the two groups of patients From the start of treatment (V0) to the end of the follow-up (V5, 8 months) The CytoMegaloVirus (CMV) levels in periodontal sample is measured through quantitative Polymerase Chain Reaction (PCR) of their viral genomes, throughout patient follow-up.
Compare frequency of periodontal surgery from visit (V3) (at periodontal reassessment) between both groups 2 months after the start of the antiviral treatment (V3) Surgery is available from visit 3 (during periodontal reassessment) and is indicated for patients with a good degree of hygiene (PI ≤ 20%) but with persistent pockets (PPS \> 5mm) and bleeding at probing
Compare changes in the Epstein-Barr Virus (EBV) levels, between the two groups of patients From the start of treatment (V0) to the end of the follow-up (V5, 8 months) The Epstein-Barr Virus (EBV) levels in periodontal sample is measured through quantitative Polymerase Chain Reaction (PCR) of their viral genomes, throughout patient follow-up.
Compare the efficacy of valaciclovir associated with conventional treatment to conventional treatment with placebo in the management of generalized periodontitis using a conventional periodontal clinical index, the O'Leary's plaque index (PI). 6 and 8 months after scaling and root planing O'Leary's Plaque Index (PI) measures the amount of plaque on the tooth (hygiene index). It is calculated by dividing the number of sites with plaque by the total number of measured sites, expressed as a percentage. This index will be collected from the same tooth that was determined for the primary objective.
Compare the efficacy of valaciclovir associated with conventional treatment to conventional treatment with placebo in the management of generalized periodontitis using a conventional periodontal clinical index, the Clinical Attachment Level (CAL). 6 and 8 months after root planing The Clinical Attachment Level (CAL) assesses the degree of impairment, by measuring the distance between the bottom of the pocket and the amelo-cemental junction of the tooth, expressed in millimeters. This index will be collected from the same tooth that was determined for the primary objective.
Compare the efficacy of valaciclovir associated with conventional treatment to conventional treatment with placebo in the management of generalized periodontitis using a conventional periodontal clinical index, the periodontal pocket depth after probing 6 and 8 months after root planing The periodontal pocket depth will be measured using a graduated (in millimeter) and coloured probe used at low pressure (\<0.2N). This index will be collected from the same tooth that was determined for the primary objective.
Compare changes in the Herpes Simplex Virus-1 (HSV-1) levels between the 2 patient groups. From the start of treatment (V0) to the end of the follow-up (V5, 8 months) The Herpes Simplex Virus-1 (HSV-1) levels in periodontal sample is measured through quantitative Polymerase Chain Reaction (PCR) of their viral genomes, throughout patient follow-up.
Compare changes of oral health impact on the quality of life of patients between both groups Before (V0), 2 months (V3) and 8 months (V5) after the start of the antiviral treatment The oral health impact on quality of life 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 patients. It will be measured before, 2 months and 8 months after the start of the antiviral treatment.
Compare changes in main bacterial species quantity of the periodontal biofilm (bacterial mapping) between both groups. Before (V0), at the end (V2) and after the antiviral treatment (V5) The twenty bacterial species levels in periodontal sample is measured through quantitative Polymerase Chain Reaction (PCR) of the bacterial genomes, before, at the end and after the antiviral treatment (V0, V2 and V5)
Evaluate the medico-economic impact of valaciclovir used with conventional treatment compared to conventional treatment alone. From the start of treatment (V0) to the end of the follow-up (V5, 8 months) The medico-economic impact is evaluated by the incremental cost-effectiveness ratio by divided the difference in the cost of each strategy to the difference in efficiency (number of patients who had therapeutical surgery during the follow-up period)
Trial Locations
- Locations (3)
CHU de Rennes
🇫🇷Rennes, Ille-et-Vilaine, France
APHM
🇫🇷Marseille, Bouches Du Rhone, France
CHU de Nice
🇫🇷Nice, Alpes Maritimes, France