Contribution of an antiviral drug (Valaciclovir) in the treatment of generalized periodontitis (stage III or IV and grade A, B or C)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Nice

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02], Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

12 Dec 2023 → ongoing

Decision date (initial)

2023-05-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Compare the efficacy of antiviral treatment (valaciclovir) with conventional non-surgical treatment (scalling, root surfacing) to conventional treatment with a placebo for generalized periodontitis (stage III or IV and grade A, B or C). This efficacy will be evaluated 28 days after the end of antiviral treatment and 2 months after root surfacing, during the periodontal re-evaluation visit

Secondary objectives 6

1. Compare the efficacy of antiviral treatment (valaciclovir) associated with conventional treatment (scaling, root surfacing) to conventional treatment alone with placebo in the management of generalized periodontitis(Stage III or IV and Grade A, B or C), 6 and 8 months after root surfacing using conventional periodontal clinical indices
2. Compare changes in the EBV, CMV and HSV-1 viruses levels (or “periodontal viral load”), between the 2 patient groups. Periodontal viral load changes will be analyzed throughout patient follow-up
3. Compare changes in main bacterial species quantity of the periodontal biofilm (bacterial mapping) before, at the end and after the antiviral treatment (V0, V2 and V5) between both groups
4. Compare frequency of periodontal surgery from visit (V3) (at periodontal reassessment) between both groups
5. Compare changes of oral health impact on the quality of life of patients between both groups
6. Evaluate the medico-economic impact of valaciclovir use with conventional treatment compared to conventional treatment alone

Conditions and MedDRA coding

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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age ≥ 18 years
2. Diagnosis of periodontitis induced by bacterial biofilms of dental plaque, generalized, stage III or IV and grade A, B or C
3. Patients of childbearing age will need to use an effective method of contraception for the duration of their study participation
4. Signature of informed consent
5. Membership of a social security scheme

Exclusion criteria 14

1. Necrotizing periodontitis
2. Pathologies requiring prophylactic antibiotic therapy (which may influence treatment)
3. Non-surgical periodontal treatment completed within 6 months prior to inclusion
4. Patients with enhanced protection, namely lactating women, persons deprived of liberty by judicial or administrative decision, persons over 18 under legal protection
5. Patients who do not accept conventional therapy (gingival debridement not covered by the social security system) performed in each centre
6. Periodontitis as a direct manifestation of systemic diseases
7. Major systemic pathologies (diabetes, HIV, cancers, immunocompromised patients)
8. Negative serology for EBV: a blood test will be performed. The results will be communicated to the patient by the dental surgeon
9. Pregnant women: a blood pregnancy test will be carried out for women of reproductive age who do not have contraception. Results will be communicated to the patient by the dental surgeon
10. Renal failure (creatinine clearance < 60 ml/min)
11. Systemic antibiotic therapy or any medication affecting the periodontal environment (systemic antibiotics, antiepileptics, immunosuppressants, calcium inhibitors) taken within 3 months of inclusion
12. Nephrotoxic medications (aminoglycosides, organoplatines, iodized contrast agents, methotrexate, pentamidine, foscarnet, ciclosporine and tacrolimus)
13. Hypersensitivity to valaciclovir, aciclovir or one of the excipients
14. History of DRESS syndrome under valaciclovir treatment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 6

1. 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
2. The EBV, CMV and HSV1 viruses levels in periodontal sample is measured through quantitative PCR of their viral genomes (DNA).
3. The twenty bacterial species level in periodontal sample is measured through quantitative PCR of the bacterial genomes (DNA).
4. 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.
5. 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.
6. 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).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Nice

Sponsor organisation

Centre Hospitalier Universitaire De Nice

Address

4 Avenue Reine Victoria

City

Nice

Postcode

06000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Nice

Contact name

Pr Séverine VINCENT-BUGNAS

Public contact point

Organisation

Centre Hospitalier Universitaire De Nice

Contact name

Laura VIALE-TRIGLIA

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications