E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Periodontitis is characterized by alveolar bone loss induced by the host immune response to bacterial insult. Because povidone iodine is known to be a powerful antiseptic, there is biologic rationale to suspect that PVI subgingival irrigations after SRP could positively affect the periodontium |
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E.1.1.1 | Medical condition in easily understood language |
Periodontitis is characterized by alveolar bone loss induced by the host immune response to bacterial insult. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of this study is to evaluate the clinical outcomes of multiple subgingival irrigations of 10% Povidone Iodine (PVI) as adjunct to scaling and root planing (SRP) in the treatment of severe generalized chronic periodontitis (GChP) |
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E.2.2 | Secondary objectives of the trial |
The objective of this study is to evaluate the clinical outcomes of multiple subgingival irrigations of 10% Povidone Iodine (PVI) as adjunct to scaling and root planing (SRP) in the treatment of severe generalized chronic periodontitis (GChP) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All subjects who are in good general health (ASA I) and were diagnosed with GChP based on the current classification of the American Academy of Periodontology will be included:
· ≥ 30 years of age
· At least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction)
· Any history of periodontal treatment in the previous 6 months
· No removable prosthesis
· A minimum of 6 teeth with at least one site each with periodontal probing depth (PPD) and clinical attachment level (CAL) ≥5 mm
· At least 30% of the sites with PPD and CAL ≥4 mm and bleeding on probing (BOP)
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E.4 | Principal exclusion criteria |
· Any sensitivity or allergy to any of the products that will be used in the study
· Thyroid dysfunction
· Systemic disease (ASA II or more)
· Need for antibiotic pre-medication for routine dental therapy
· Antibiotic therapy in the previous 3 months
· Pregnancy and breastfeeding
· Current smokers (more than 5 cigarettes a day)
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of this study is to determine the effect of PVI on periodontal probing depth (PPD).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
The secondary objectives are to determine the effect of PVI on parameters associated with periodontal health such as clinical attachment level (CAL) and bleeding on probing (BOP) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |