Antimicrobial Photodynamic Therapy in Treatment of Aggres... | NCT05655338

Studies
Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis (Stage III, Grade C Periodontitis)

NCT05655338

Sponsor

University of Ljubljana

Status

Completed

Last Update Posted

Dec 19, 2022Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Aggressive Periodontitis

Interventions

antimicrobial photodynamic therapy
systemic antibiotics

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2015Actual

Primary Completion Date

Jun 30, 2016Actual

Completion Date

Jun 30, 2016Actual

First Submitted Date

Nov 23, 2022

First Submission Date that Met QC Criteria

Dec 8, 2022

First Posted Date

Dec 19, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2022

Last Update Posted Date

Dec 19, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Treatment of aggressive periodontitis (stage III, grade C periodontitis) represents a big challenge. The aim of the study was to compare the long-term results of antimicrobial photodynamic therapy (aPDT) and antibiotic therapy as an adjunct to conventional non-surgical therapy in patients with aggressive periodontitis. Clinical parameters of probing depth, clinical attachment level and bleeding on probing (BOP) were assessed at baseline, 3, 6, 9 and 12 months after treatment.

Detailed Description

Background: Treatment of aggressive periodontitis (stage III, grade C periodontitis) represents a big challenge. The aim of the study was to compare the long-term results of antimicrobial photodynamic therapy (aPDT) and antibiotic therapy as an adjunct to conventional non-surgical therapy in patients with aggressive periodontitis. Materials and methods: Twenty subjects with untreated aggressive periodontitis (stage III, grade C periodontitis) were divided into two groups: the test group (TG) received non-surgical therapy and two sessions of aPDT using a laser (HELBO TheraLite laser) with a wavelength of 670nm associated with HELBO Blue photosensitizer, and the control group (CG) received non-surgical therapy and antibiotics (amoxicillin 500mg and metronidazole 400mg, 7 days). Clinical parameters of probing depth, clinical attachment level and bleeding on probing (BOP) were assessed at baseline, 3, 6, 9 and 12 months after treatment.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ANTIMICROBIAL PHOTODYNAMIC THERAPY	Experimental	The patients received antimicrobial photodynamic therapy after non-surgical periodontal treatment	Device: antimicrobial photodynamic therapy
SYSTEMIC ANTIBIOTICS	Experimental	The patients received systemic antibiotics after non-surgical periodontal treatment	Drug: systemic antibiotics

Interventions

Name	Type	Description	Arm Group Labels	Other Names
antimicrobial photodynamic therapy	Device		ANTIMICROBIAL PHOTODYNAMIC THERAPY	HELBO TheraLite Laser

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Probing depth reduction	Change in probing depth	3 months
Bleeding on probing	Bleeding after measurement of probing depth	3 months

Secondary Outcomes

Measure	Description	Time Frame
Clinical attachment loss	Change in clinical attachment	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aggressive periodontitis (stage III, grade C periodontitis)
nonsmokers
at least 20 teeth in oral cavity
systemically healthy

Exclusion Criteria:

any previous periodontal treatment
smoking
pregnancy
ingestion of systemic antibiotics within three months before therapy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Boris Gaspirc, Assoc.prof.	University of Ljubljana	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010520	Aggressive Periodontitis

Ancestor Terms

ID	Term
D010518	Periodontitis
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000658	Amoxicillin
D008795	Metronidazole

Ancestor Terms

ID	Term
D000667	Ampicillin
D010400	Penicillin G
D010406	Penicillins
D047090	beta-Lactams
D007769

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Single

Masking Description

The blindness of the examiner was ensured by restriction of access to the patients' data. Only the supervisor (MP) had access to the allocation data and therefore knew which patients received additional aPDT treatment.

Periodontal examinations of 5 randomly selected individuals were carried out twice by the same examiner, and the second measurements were repeated after two weeks. The reproducibility of assessing all periodontal parameters was tested. Intra-examiner calibration scores were 0.95.

Who Masked

Care Provider