Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-25 @ 4:12 AM
Study NCT ID:
NCT01670305
Status:
COMPLETED
Last Update Posted:
2013-09-12
First Post:
2012-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photodynamic Therapy and Periodontal Therapy. A Clinical, Microbiological and Immunoenzymatic Analysis
Sponsor:
Paulista University
Organization:
Study Overview
Official Title:
Photodynamic Therapy and Periodontal Therapy. A Clinical, Microbiological and Immunoenzymatic Analysis.
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Residual pockets and furcation defects are challenging sites that require additional periodontal therapy. The aim of this study is evaluate 1)the effect of a single photodynamic therapy (PDT) as monotherapy residual pockets in single rooted teeth and 2) the effect of PDT in association with scaling and root planing (SRP) in class II furcation lesions with probing pocket depth (PPD) \>5mm and bleeding on probing (BoP). A blind randomized controlled clinical trial was conducted in subjects presenting at least three residual pockets in single root teeth and subjects with at least one molar presenting class II furcation defect. To evaluate the effect of a single PDT as monotherapy in residual pockets, the selected sites were assigned to receive: PDT alone, photosensitizer alone or SRP alone. To evaluate the effect of PDT in association with SRP in class II furcation lesions, the selected sites were assigned to PDT+SRP or SRP alone. Clinical, microbiological and immunoenzymatic analyses were assessed at baseline, 3 and 6 months post-therapies.
Detailed Description:
Residual pockets and class II furcation lesions are challenging sites that require additional periodontal therapy. The aims of this study were to evaluate:
1\) the effect of a single PDT as monotherapy residual pockets in single rooted teeth and 2) the effect of PDT in association with SRP in class II furcation lesions.
A blind randomized controlled clinical trial was conducted in subjects presenting at least three residual pockets in single root teeth and subjects with at least one molar presenting class II furcation involvement.
To evaluate the effect of a single PDT as monotherapy in residual pockets, the selected sites were assigned to receive one of following therapies: PDT alone, photosensitizer alone or SRP alone.
To evaluate the effect of PDT in association with SRP in class II furcation lesions, the selected sites were assigned to receive PDT+SRP or SRP alone. Microbiological, immunoenzymatic analyses and clinical parameters: probing pocket depth (PPD), position of the gingival margin (PGM), relative clinical attachment level (RCAL), full mouth plaque (FMPS) and bleeding score (FMBS), will be assessed at baseline,3 and 6 months post-therapies.
1\) the effect of a single PDT as monotherapy residual pockets in single rooted teeth and 2) the effect of PDT in association with SRP in class II furcation lesions.
A blind randomized controlled clinical trial was conducted in subjects presenting at least three residual pockets in single root teeth and subjects with at least one molar presenting class II furcation involvement.
To evaluate the effect of a single PDT as monotherapy in residual pockets, the selected sites were assigned to receive one of following therapies: PDT alone, photosensitizer alone or SRP alone.
To evaluate the effect of PDT in association with SRP in class II furcation lesions, the selected sites were assigned to receive PDT+SRP or SRP alone. Microbiological, immunoenzymatic analyses and clinical parameters: probing pocket depth (PPD), position of the gingival margin (PGM), relative clinical attachment level (RCAL), full mouth plaque (FMPS) and bleeding score (FMBS), will be assessed at baseline,3 and 6 months post-therapies.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: