Comparison Between Surgical Access and Repeated Applications of APDT

NCT03140059 | Unknown

• 1 other identifier: SurgeryPDT
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study will be to compare the approach of repeated applications of APDT versus surgical therapy for the treatment of residual pockets in generalized agressive periodontitis.

Conditions

Aggressive Periodontitis, Generalized

Keywords

surgical procedure; residual pockets; agressive periodontitis; antimicrobial photodynamic therapy

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level

  6 months

Secondary Outcomes (1)

• Probing depth

  6 months

Study Arms (2)

Open flap debridement

ACTIVE COMPARATOR

In this group (n = 22), patients will receive open flap debridement will be performed to treat residual pockets.

Procedure: Open flap debridement

Repeated application of aPDT

ACTIVE COMPARATOR

In this group (n=22), patients will receive 5 applications of antimicrobial photodynamic therapy after the scaling and root planing.

Procedure: Repeated application of aPDT

Interventions

Open flap debridement PROCEDURE

Open flap debridement will be performed to decontaminate root surface

Also known as: Surgical therapy

Open flap debridement

Repeated application of aPDT PROCEDURE

Repeated application of photodynamic therapy (aPDT) at 0, 1, 2, 7 and 14 days post-operatively.

Repeated application of aPDT

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of generalized aggressive periodontitis (Armitage, 1999; American Academy of Periodontology, 2015);
• Have undergone a first approach for periodontal treatment (full-mouth ultrasonic debridement);
• Present at least one residual pocket of probing depth ≥ 5 mm and bleeding on probe not located in furcation region;
• Good general health;
• Agree to participate in the study and sign the informed consent form (TCLE) after explaining the risks and benefits;

You may not qualify if:

• Systemic problems (cardiovascular alterations, blood dyscrasias, immunodeficiency - ASA III / IV / V) that contraindicate the periodontal procedure;
• Have used antibiotics and anti-inflammatories in the last six months;
• Smoke ≥ 10 cigarettes/day;
• Pregnant or lactating;
• Chronic use of medications that may alter the response of periodontal tissues;
• Indication of antibiotic prophylaxis for dental procedures;

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Related Publications (1)

• Lulic M, Leiggener Gorog I, Salvi GE, Ramseier CA, Mattheos N, Lang NP. One-year outcomes of repeated adjunctive photodynamic therapy during periodontal maintenance: a proof-of-principle randomized-controlled clinical trial. J Clin Periodontol. 2009 Aug;36(8):661-6. doi: 10.1111/j.1600-051X.2009.01432.x. Epub 2009 Jun 25.

  PMID: 19563331 BACKGROUND

MeSH Terms

Conditions

Aggressive Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mauro P Santamaria, DDS, PhD

  Universidade Estadual Paulista "Julio de Mesquita Filho", ICT/UNESP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS,MS,PhD

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 4, 2017
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: March 1, 2018
• Last Updated: October 18, 2017

Record last verified: 2017-10