Comparison Between Surgical Access and Repeated Applications of APDT

NCT ID: NCT03140059

Last Updated: 2017-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-03-31

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.

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.

Conditions

Aggressive Periodontitis, Generalized

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Open flap debridement

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

Group Type: ACTIVE_COMPARATOR

Open flap debridement

Intervention Type: PROCEDURE

Open flap debridement will be performed to decontaminate root surface

Repeated application of aPDT

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

Group Type: ACTIVE_COMPARATOR

Repeated application of aPDT

Intervention Type: PROCEDURE

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

Interventions

Open flap debridement

Open flap debridement will be performed to decontaminate root surface

Intervention Type: PROCEDURE

Repeated application of aPDT

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

Intervention Type: PROCEDURE

Other Intervention Names

Surgical therapy

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role: lead

Responsible Party

Mauro Pedrine Santamaria

DDS,MS,PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mauro P Santamaria, DDS, PhD

Role: STUDY_DIRECTOR

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

References

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.

Reference Type: BACKGROUND

PMID: 19563331 (View on PubMed)

Other Identifiers

SurgeryPDT

Identifier Type: -

Identifier Source: org_study_id