Evaluation of multiple subgingival irrigations with 10% povidone iodine after scaling and root planing

Evaluation of multiple subgingival irrigations with 10% povidone iodine after scaling and root planing : a randomized clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004493-34-BE

Enrollment

Registered

2017-12-08

Start date

2018-01-02

Completion date

Unknown

Last updated

2023-10-23

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

Conditions

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

Interventions

Trade Name: iso-BETADINE Dermique 10 %, solution pour application cutanée Product Name: Povidone iodine dermique 10% Pharmaceutical Form: Cutaneous solution INN or Proposed INN: iso- BETADINE Dermiqu

Eligibility

Sex/Gender

All

Inclusion criteria

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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: 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);Secondary Objective: 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);Primary end point(s): The primary objective of this study is to determine the effect of PVI on periodontal probing depth (PPD). ;Timepoint(s) of evaluation of this end point: up to 6 months	—

Measure

Time frame

Main Objective: 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);Secondary Objective: 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);Primary end point(s): The primary objective of this study is to determine the effect of PVI on periodontal probing depth (PPD). ;Timepoint(s) of evaluation of this end point: up to 6 months

—

Secondary

Measure	Time frame
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);Timepoint(s) of evaluation of this end point: up to 6 months	—

Countries

Belgium

Contacts

Public ContactSponsor

Cliniques universitaires Saint-Luc

selena.toma@uclouvain.be003227645714

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026