The aim of this study is to investigate whether adjunctive phototherapy (along with common periodontal treatment) in patients undergoing chemotherapy leads to an improvement of the periodontal status or not
Design
A single blinded clinical trial with a control group and a parallel design
R Software will be used for minimization randomization
Settings and conduct
This randomized, single-blinded trial will be conducted in a dental clinic and a specialized oncology center. All eligible patients will be assigned to intervention and control groups. Both groups will receive SRP in one session and the control group will be left until the end of a chemotherapy period.
The intervention group will receive adjuvant phototherapy along with SRP.
After the start of the first chemotherapy session, the patients in the intervention group will be treated with a 630 nm wavelength and energy density of 2 J/cm2 laser for one day between the end of a chemotherapy period, and the involved and non-involved areas of the mouth will be treated with laser therapy. At 7 and 14 days, the main outcome parameters will be measured by a blinded investigator. Codes and numbers will be used to make outcome assessor blinded.
Participants/Inclusion and exclusion criteria
Patients <65 years undergoing chemotherapy with at least one tooth with periodontal disease will be included. Lactating and pregnant women and patients who have received interventional drugs on the periodontal condition in the last 6 months will be excluded
Intervention groups
One group of patients will receive routine periodontal treatment during a period of chemotherapy (usually within two weeks) and the other group will receive phototherapy treatment along with routine treatment.
Main outcome variables
Plaque Index; Gingival Index; Pocket Depth; Bleeding on Probing; Pain/burning
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221224056905N1
Registration date:2023-01-17, 1401/10/27
Registration timing:prospective
Last update:2023-01-17, 1401/10/27
Update count:0
Registration date
2023-01-17, 1401/10/27
Registrant information
Name
Parsa Firoozi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3374 2485
Email address
parsafir2@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the adjunctive effects of phototherapy in improving periodontal status in cancer patients during chemotherapy
Public title
Effects of phototherapy in improving periodontal status in cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
presence of periodontal disease at least in one tooth
Age < 65 years
Exclusion criteria:
Pregnancy or lactating
Medication (i.e., antibiotics) affecting periodontal status
Not receiving routine periodontal treatment (SRP) in the last 6 months
Age
To 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Covariate Adaptive Randomization (Minimization)
Randomization Unit: Stratified
Randomization tool: R statistical software (CARAT package)
Making random sequence: In this method, the first participant is randomly assigned to one of the groups, and the next participants are assigned to a group in order to balance the allocation according to the predetermined covariate variables.
Allocation concealment: using numbered, sealed, and opaque envelopes
Blinding (investigator's opinion)
Single blinded
Blinding description
According to the specific conditions of cancer patients, they will be fully informed about the type of intervention. Due to the nature of the intervention (photobiomodulation + SRP vs. SRP alone), the main researcher who is in charge of the intervention is also aware of the type of intervention. However, a separate blinded investigator is considered for accurate measurement of periodontal parameters.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of AJA University of Medical Sciences
Street address
AJA University of Medical Sciences, School of Dentistry, Misaq Complex, East 13th Street, Ajudaniyeh, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1111111111
Approval date
2022-12-17, 1401/09/26
Ethics committee reference number
IR.AJAUMS.REC.1401.153
Health conditions studied
1
Description of health condition studied
periodontal disease
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases
Primary outcomes
1
Description
Plaque Index
Timepoint
Baseline, 7, 14 days after starting chemotherapy period
Method of measurement
The plaque index quantitatively assesses the amount of dental plaque visible on the surfaces of all teeth, except the third molars
2
Description
Gingival Index
Timepoint
Baseline, 7, 14 days after starting chemotherapy period
Method of measurement
The Gingival Index (GI) scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding
3
Description
Bleeding on probing (BoP)
Timepoint
Baseline, 7, 14 days after starting chemotherapy period
Method of measurement
Visual evaluation of bleeding
4
Description
Pain/Burning
Timepoint
Baseline, 7, 14 days after starting chemotherapy period
Method of measurement
Visual Analogue Scale
5
Description
Probing Depth
Timepoint
Baseline, 7, 14 days after starting chemotherapy period
Method of measurement
The distance measured from the base of the pocket to the most apical point on the gingival margin.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In a 14-day period of chemotherapy, patients after receiving routine periodontal treatment (SRP), one day between and at the end of a period of chemotherapy with the help of a laser with a wavelength of 630 nm and an energy density of 2 J/cm2 (for the purpose of photobiomodulation) involved and non-involved areas of the mouth will be irradiated. In time intervals of 0 days, 7 days, and 14 days after starting chemotherapy period, the areas inside the patient's mouth will be assessed for changes in periodontal parameters.
Category
Treatment - Other
2
Description
Control group: In a 14-day period of chemotherapy, these patients will receive only routine periodontal treatment (SRP).