Comparison Between Surgical Access and Repeated Applications of APDT

Aggressive Periodontitis, Generalized Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03140059
• Other study ID #: SurgeryPDT
• Status: Active, not recruiting
• Phase: N/A
• First received: May 2, 2017
• Last updated: October 16, 2017
• Start date: June 2016
• Est. completion date: March 2018

Study information

• Verified date: October 2017
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: March 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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;

Related Conditions & MeSH terms

• Aggression
• Aggressive Periodontitis
• Aggressive Periodontitis, Generalized
• Periodontitis

Intervention

Procedure:
• Open flap debridement
Open flap debridement will be performed to decontaminate root surface
• Repeated application of aPDT
Repeated application of photodynamic therapy (aPDT) at 0, 1, 2, 7 and 14 days post-operatively.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

References & Publications (1)

Lulic M, Leiggener Görög 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical attachment level		6 months
Secondary	Probing depth		6 months