Chronic PeriodontitisNCT03770819
PDT As An Adjunct To SRP In The Management of Chronic Periodontitis
A study testing Photodynamic therapy in people with Chronic Periodontitis, run by KLE Society's Institute of Dental Sciences.
Trial summary
The present study aims to evaluate photodynamic therapy (PDT) using Zinc oxide as a photosensitizer as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Photodynamic therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients of both genders diagnosed with chronic periodontitis in the age group of 30 to 50 years with good systemic health.
- Presence of a minimum of 20 teeth and at least one site with probing pocket depth (PPD) of 4-7 mm and clinical attachment level (CAL) of 2 mm or greater, in each of the four quadrants.
Who cannot join
- Patients who have undergone periodontal therapy during the previous 6 months of commencement of the study.
- Subjects on antibiotics or immunosuppressant medication 6 months prior to the study.
- Chronic Smokers, Alcoholics, Smokeless tobacco users.
- Subjects with acute illnesses/acute intraoral lesions.
- Pregnant women and lactating mothers.
- Medically compromised subjects.
About this study
Official title: Photodynamic Therapy Using Zinc Oxide Photosensitizer As An Adjunct To Scaling And Root Planing In The Management Of Chronic Periodontitis - A Split Mouth Double Blind Randomized Controlled Clinical Trial.
The present study aims to evaluate photodynamic therapy (PDT) using Zinc oxide as a photosensitizer as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis.
Read the detailed description
Following full mouth SRP, each quadrant will be randomly assigned by simple randomization using a computer generated randomization technique into one of the following four treatment modalities.
Group 1 (control) - Application of placebo gel followed by sham PDT (Directing the Light cure device without turning on the light beam).
Group 2 -Application of Zinc oxide gel followed by sham PDT. Group 3 - Application of placebo gel followed by PDT. Group 4 - Application of Zinc oxide gel followed by PDT. The procedure mentioned for each group will be performed on all periodontal pockets in the assigned quadrant at baseline, end of 1 week and 1 month from the first session.
Clinical parameters and microbial profile will be recorded at baseline (before commencement of Periodontal treatment), end of 1 month and end of 3 months following periodontal treatment.
Zinc oxide gel/placebo gel will be placed into the periodontal pockets using a blunt cannula ensuring that starting from the bottom, it completely fills the periodontal pockets. The gel will be retained in the pocket for 5 minutes. The perio tip will be attached to the hand piece of the light cure unit (Wavelength: 420-480nm. Light power: 1200mw/cm2 in continuous mode) and light will be activated for 60 seconds. Following this, the pockets will be irrigated with normal saline solution (0.9%Sodium chloride).
- Conditions
- Chronic Periodontitis
- Being tested
- Photodynamic therapy
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic therapyProcedure or surgery
Zinc oxide gel/placebo gel will be placed into the periodontal pockets using a blunt cannula ensuring that starting from the bottom, it completely fills the periodontal pockets. The gel will be retained in the pocket for 5 minutes. The perio tip will be attached to the hand piece of the light cure unit (Wavelength: 420-480nm. Light power: 1200mw/cm2 in continuous mode) and light will be activated for 60 seconds. Following this, the pockets will be irrigated with normal saline solution (0.9%Sodium chloride).
For groups 1 and 2, sham PDT will be performed by directing the Light cure device without turning on the light beam.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Application of placebo gel followed by sham Photodynamic therapy Receives: Procedure: Photodynamic therapy |
| Zinc oxide gel group | Active comparator | Application of Zinc oxide gel followed by sham Photodynamic therapy. Receives: Procedure: Photodynamic therapy |
| PDT group | Experimental | Application of placebo gel followed by Photodynamic therapy. Receives: Procedure: Photodynamic therapy |
| Zinc oxide and PDT group | Experimental | Application of Zinc oxide gel followed by Photodynamic therapy. Receives: Procedure: Photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Microbial profile
Change in levels of P.gingivalis following PDT
Measured: 3 months
Secondary outcomes (4)
Change in Plaque index score
Change in plaque index score from Range: 2-3 to Range: 0 to1.9 following PDT
Measured: 3 months
Change in Gingival index score
Change in Gingival index score from Range: 2-3 to Range: 0 to1.9 following PDT
Measured: 3 months
Probing pocket depth
Change in probing pocket depth from 5-7 mm to 2.9- 4.2 mm following PDT
Measured: 3 months
Clinical attachment level
Gain in clinical attachment level following PDT
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study startMar 2019 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 16 patients contributing a total of 64 sites will be selected. Recording of clinical and microbiological parameters will be done at baseline, end of 1 month, and 3 months. Oral hygiene instructions will be given. Following full mouth SRP, each quadrant will be randomly assigned by simple randomization using a computer generated randomization technique into one of the following four treatment modalities. Group 1 (control) - Application of placebo gel followed by sham PDT (Directing the Light cure device without turning on the light beam). Group 2 -Application of Zinc oxide gel followed by sham PDT. Group 3 - Application of placebo gel followed by PDT. Group 4 - Application of Zinc oxide gel followed by PDT. The procedure mentioned for each group will be performed on all periodontal pockets in the assigned quadrant at baseline, end of 1 week and 1 month from the first session. Study period - 3 months
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KLE Society's Institute of Dental Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Mysore
- Responsible party
- Principal investigator, Veena H.R, KLE Society's Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770819
- Sponsor's protocol ID
- KIDSperio-PDT
- Status last verified
- Feb 2019
- First submitted
- 6 Dec 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy Using Zinc Oxide Photosensitizer As An Adjunct To Scaling And Root Planing In The Management Of Chronic Periodontitis - A Split Mouth Double Blind Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03770819
- Acronym / sponsor ID
- KIDSperio-PDT
- Conditions
- Chronic Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- KLE Society's Institute of Dental SciencesUniversity, hospital or other
- Collaborators
- University of Mysore
- Study start
- Mar 2019 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 10 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aims to evaluate photodynamic therapy (PDT) using Zinc oxide as a photosensitizer as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis.
Detailed description
Following full mouth SRP, each quadrant will be randomly assigned by simple randomization using a computer generated randomization technique into one of the following four treatment modalities.
Group 1 (control) - Application of placebo gel followed by sham PDT (Directing the Light cure device without turning on the light beam).
Group 2 -Application of Zinc oxide gel followed by sham PDT. Group 3 - Application of placebo gel followed by PDT. Group 4 - Application of Zinc oxide gel followed by PDT. The procedure mentioned for each group will be performed on all periodontal pockets in the assigned quadrant at baseline, end of 1 week and 1 month from the first session.
Clinical parameters and microbial profile will be recorded at baseline (before commencement of Periodontal treatment), end of 1 month and end of 3 months following periodontal treatment.
Zinc oxide gel/placebo gel will be placed into the periodontal pockets using a blunt cannula ensuring that starting from the bottom, it completely fills the periodontal pockets. The gel will be retained in the pocket for 5 minutes. The perio tip will be attached to the hand piece of the light cure unit (Wavelength: 420-480nm. Light power: 1200mw/cm2 in continuous mode) and light will be activated for 60 seconds. Following this, the pockets will be irrigated with normal saline solution (0.9%Sodium chloride).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- 16 patients contributing a total of 64 sites will be selected. Recording of clinical and microbiological parameters will be done at baseline, end of 1 month, and 3 months. Oral hygiene instructions will be given. Following full mouth SRP, each quadrant will be randomly assigned by simple randomization using a computer generated randomization technique into one of the following four treatment modalities. Group 1 (control) - Application of placebo gel followed by sham PDT (Directing the Light cure device without turning on the light beam). Group 2 -Application of Zinc oxide gel followed by sham PDT. Group 3 - Application of placebo gel followed by PDT. Group 4 - Application of Zinc oxide gel followed by PDT. The procedure mentioned for each group will be performed on all periodontal pockets in the assigned quadrant at baseline, end of 1 week and 1 month from the first session. Study period - 3 months
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Procedure: Photodynamic therapyApplication of placebo gel followed by sham Photodynamic therapy |
| Zinc oxide gel group | Active comparator | Procedure: Photodynamic therapyApplication of Zinc oxide gel followed by sham Photodynamic therapy. |
| PDT group | Experimental | Procedure: Photodynamic therapyApplication of placebo gel followed by Photodynamic therapy. |
| Zinc oxide and PDT group | Experimental | Procedure: Photodynamic therapyApplication of Zinc oxide gel followed by Photodynamic therapy. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients of both genders diagnosed with chronic periodontitis in the age group of 30 to 50 years with good systemic health.
- Presence of a minimum of 20 teeth and at least one site with probing pocket depth (PPD) of 4-7 mm and clinical attachment level (CAL) of 2 mm or greater, in each of the four quadrants.
Key exclusion criteria (6 listed)
- Patients who have undergone periodontal therapy during the previous 6 months of commencement of the study.
- Subjects on antibiotics or immunosuppressant medication 6 months prior to the study.
- Chronic Smokers, Alcoholics, Smokeless tobacco users.
- Subjects with acute illnesses/acute intraoral lesions.
- Pregnant women and lactating mothers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photodynamic therapyZinc oxide gel/placebo gel will be placed into the periodontal pockets using a blunt cannula ensuring that starting from the bottom, it completely fills the periodontal pockets. The gel will be retained in the pocket for 5 minutes. The perio tip will be attached to the hand piece of the light cure unit (Wavelength: 420-480nm. Light power: 1200mw/cm2 in continuous mode) and light will be activated for 60 seconds. Following this, the pockets will be irrigated with normal saline solution (0.9%Sodium chloride). For groups 1 and 2, sham PDT will be performed by directing the Light cure device without turning on the light beam. | Procedure or surgery | PDT group, Placebo group, Zinc oxide and PDT group, Zinc oxide gel group |
Primary outcome
Change in Microbial profile
Time frame: 3 months
Change in levels of P.gingivalis following PDT
4 secondary outcomes
Change in Plaque index score
Time frame: 3 months
Change in Gingival index score
Time frame: 3 months
Probing pocket depth
Time frame: 3 months
Clinical attachment level
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Photodynamic therapy in people with Chronic Periodontitis, run by KLE Society's Institute of Dental Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Microbial profile (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.