- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04037709
Photodynamic Therapy in Patients With Gingivitis
Efficacy of Photodynamic Therapy and Scraping in Patients With Gingivitis Predisposed by Fixed Orthodontic Appliances: Randomized, Controlled, Double-blind, Split-mouth Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anna Carolina RT Horliana, phd
- Phone Number: 5513981999848 5513981999848
- Email: annacrth@gmail.com
Study Contact Backup
- Name: Renata M Negreiros, phd
- Phone Number: 5513981999848 5511981588472
- Email: renata.matalon@gmail.com
Study Locations
-
-
SP
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São Paulo, SP, Brazil, 11030-480
- Anna Carolina R.T. Horliana
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- healthy participants (negative medical history),
- of both genders,
- aged 10 to 30 years,
- with gingivitis induced by dental biofilm,
- predisposed by the use of a fixed orthodontic appliance, according to the classification of 2018
Exclusion Criteria:
- participants with maxillary and mandibular deformities,
- periodontitis,
- oral lesions and who have used antibiotics for less than 3 months,
- those who have used non-steroidal anti-inflammatory drugs and continuous corticosteroid therapy for less than 3 months,
- who have been using mouthwash in the past 3 months.
- Participants who have modifying factors for periodontal disease, such as diabetics, immunosuppressive smokers (cyclosporine), anticonvulsants (phenytoin), calcium channel blockers (nifedipine) and pregnant and lactating women as well as those who are HIV positive, or have Hepatitis B or C. - Patients who require prophylactic antibiotic therapy for periodontal treatment - who have had periodontal treatment in the last 6 months.
- Patients who have non-biofilm-induced gum disease.
- Patients who for some reason during the study have to initiate the use of the medicines and mouthwashes mentioned above or acquire a disease that is a modifying factor for periodontal disease or become pregnant.
- Patients who do not wish to remain part of the study may drop out whenever they wish.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: scaling and root planing (SRP) + PDT placebo
17 patients will receive periodontal treatment (scaling and root planing - SRP) with the ultrasound. The SRP will be done in one session. SRP will be performed by only one experienced researcher. Periodontal reassessment will be performed after 30 days. The PDT placebo wil be done using an agent with the same vehicle as that of the methylene blue to mimic irrigation with the photosensitizer; the laser will be switched off at the time of application. |
Patientes will receive periodontal treatment (scaling and root planing - SRP) with the ultrasound.
The SRP will be done in one session.
The PDT placebo wil be done using an agent with the same vehicle as that of the methylene blue to mimic irrigation with the photosensitizer; the laser will be switched off at the time of application.
|
Experimental: scaling and root planing (SRP) + PDT
17 patients will receive the same scaling and root planing treatment that placebo group. However the PDT will be done only on one side of the mouth using methylene blue 0.005% - Chimiolux 5, DMC - purified water and methylene blue.The red laser diode (λ = 660 nm) will be applied with an output power of 100mW . The laser head will be positioned in direct contact with the pseudo periodontal pocket. |
patients will receive the same scaling and root planing treatment that placebo group.However the PDT will be done only on one side of mouth using methylene blue 0.005% .The red laser diode (λ = 660 nm) will be applied with an output power of 100mW .
The laser head will be positioned in direct contact with the pseudo periodontal pockets.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gingival bleeding index
Time Frame: through study completion on average of one year
|
The periodontal probe will be inserted at all predetermined sites at the gingival margin of all teeth, 30 seconds will be waited and, at the smallest sign of bleeding, the presence or absence of bleeding will be noted.
Gingival bleeding will be evaluated at 4 sites (mesiobuccal, distobuccal, mesiolingual, distolingual.The gingival Index will be presented in a percentage (%).
The result will be based on the ratio of total sites to sites affected.
Results will be considered indicative of gingivitis with ≥ 10% bleeding .
It will be assessed at baseline and 30 days after treatment.
|
through study completion on average of one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical probing depth (PD)
Time Frame: through study completion on average of one year
|
Will be done by a calibrated evaluator using a periodontal probe marked in millimeters (North Carolina University periodontal probe, UNC-15 (Hu-FriedyTM): all teeth (except third molars) will be evaluated at 4 sites (mesiobuccal, distobuccal, mesiolingual, distolingual) using the aforementioned parameters. The Northe Carolina University periodontal probe will be insert in the gingival sulcus. Probing depths to be evaluated in millimeters (mm) from the base of the periodontal pocket to the free gingival margin. It will be assesed at baseline and 30 days after treatment. |
through study completion on average of one year
|
Evaluation of crevicular fluid cytokines IL-6, IL-1β, and IL-10,
Time Frame: through study completion on average of one year
|
Evaluation of cytokines IL-6, IL-1β, , and IL-10, will be done via the ELISA.
The paper cones will be inserted at regions with gingivitis and gingival hyperplasia (pseudo pocket) until resistance be felt.
The cone will remain in this position for 30 seconds.
If there is blood contamination a new cone will be used after 90 seconds.
Eight cones must be collected, one for each site.
The cones will be placed in a 1.5ml microcentrifuge tube and stored at -80 °C.
It will be assesed at baseline and 30 days after treatment;
|
through study completion on average of one year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visible plaque index (PI)
Time Frame: through study completion on average of one year
|
Will be visualy evalueted before of probing depht, using the following score of visible supragingival plaque: Presence = 1 Absence = 0 It will be assessed at baseline and 30 days after treatment |
through study completion on average of one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anna Carolina R Horliana, phd, Nove de Julho University
Publications and helpful links
General Publications
- Schalch TO, Palmieri M, Longo PL, Braz-Silva PH, Tortamano IP, Michel-Crosato E, Mayer MPA, Jorge WA, Bussadori SK, Pavani C, Negreiros RM, Horliana ACRT. Evaluation of photodynamic therapy in pericoronitis: Protocol of randomized, controlled, double-blind study. Medicine (Baltimore). 2019 Apr;98(17):e15312. doi: 10.1097/MD.0000000000015312.
- Gomez C, Abellan R, Palma JC. Efficacy of photodynamic therapy vs ultrasonic scaler for preventing gingival inflammation and white spot lesions during orthodontic treatment. Photodiagnosis Photodyn Ther. 2018 Dec;24:377-383. doi: 10.1016/j.pdpdt.2018.11.001. Epub 2018 Nov 3.
- Chapple ILC, Mealey BL, Van Dyke TE, Bartold PM, Dommisch H, Eickholz P, Geisinger ML, Genco RJ, Glogauer M, Goldstein M, Griffin TJ, Holmstrup P, Johnson GK, Kapila Y, Lang NP, Meyle J, Murakami S, Plemons J, Romito GA, Shapira L, Tatakis DN, Teughels W, Trombelli L, Walter C, Wimmer G, Xenoudi P, Yoshie H. Periodontal health and gingival diseases and conditions on an intact and a reduced periodontium: Consensus report of workgroup 1 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S74-S84. doi: 10.1002/JPER.17-0719.
- Rosa EP, Murakami-Malaquias-Silva F, Schalch TO, Teixeira DB, Horliana RF, Tortamano A, Tortamano IP, Buscariolo IA, Longo PL, Negreiros RM, Bussadori SK, Motta LJ, Horliana ACRT. Efficacy of photodynamic therapy and periodontal treatment in patients with gingivitis and fixed orthodontic appliances: Protocol of randomized, controlled, double-blind study. Medicine (Baltimore). 2020 Apr;99(14):e19429. doi: 10.1097/MD.0000000000019429.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PDT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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