Comparison Between Surgical Access and Repeated Applications of APDT

Comparison Between Surgical Access and Repeated Applications of APDT to Residual Pockets Treatment in Generalized Aggressive Periodontitis: Randomized Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Aggressive Periodontitis, Generalized
• Intervention / Treatment: Procedure: Open flap debridement; Procedure: Repeated application of aPDT

Detailed Description

Scaling and root planing may be insufficient to resolve the periodontal infection resulting in residual periodontal pockets. A method of treatment to these sites would be the surgical therapy, because it allows access to root surfaces, making possible a better decontamination. However, the surgical approach may bring some negative points, as more discomfort and postoperative morbidity, increased transoperatory risk and increased risk of contamination. Thus, finding other alternatives to residual pockets treatment, antimicrobial photodynamic therapy (aPDT) was recently proposed. Therefore, 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.

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Open flap debridement; In this group (n = 22), patients will receive open flap debridement will be performed to treat residual pockets.	Procedure: Open flap debridement; Open flap debridement will be performed to decontaminate root surface; Other Names: Surgical therapy
Active Comparator: Repeated application of aPDT; 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; Repeated application of photodynamic therapy (aPDT) at 0, 1, 2, 7 and 14 days post-operatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical attachment level	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Probing depth	6 months

Collaborators and Investigators

• Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
• Investigators: Study Director: Mauro P Santamaria, DDS, PhD, Universidade Estadual Paulista "Julio de Mesquita Filho", ICT/UNESP

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 4, 2017

Study Record Updates

• Last Update Posted (Actual): October 18, 2017
• Last Update Submitted That Met QC Criteria: October 16, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: residual pockets; antimicrobial photodynamic therapy; surgical procedure; agressive periodontitis
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Aggression; Periodontitis; Aggressive Periodontitis
• Other Study ID Numbers: SurgeryPDT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No