PeriodontitisPhase 2NCT04374383
Novel Photosensitizer in The Treatment of Chronic Periodontitis
A Phase 2 study testing Phthalocyanine Dye and LASER assisted SRP in people with Periodontitis and Alveolar Bone Loss, run by SVS Institute of Dental Sciences at 2 sites in India.
Trial summary
The aim of this study is to evaluate the periodontal outcomes after applying antimicrobial photodynamic therapy with a novel photosensitizer as compared to LASER assisted scaling and root planing alone. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Alveolar Bone Loss
- What is being tested?
- Phthalocyanine Dye and LASER assisted SRP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Jun 2019to Nov 2021
- Phase
- Phase 2
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy male and female patients of age 30-60 years with generalized probing pocket depths (PPD) indicative of chronic periodontitis and with atleast two sites with PPD ≥5mm in each quadrant
Who cannot join
- Medically compromised patients, Subjects with a history of periodontal intervention within 6 months of the commencement of the study and smokers
Trial locations and contacts
2 sites in 1 country.
India2 sites, 2 recruiting
- Recruiting
R V Chandra
Hyderabad, Telangana, 509002
R V Chandra, MDS;DNB;PhD, 9908183071, viswachandra@hotmail.com
- Recruiting
SVS Institute of Dental Sciences
Hyderabad, Telangana, 509002
RVchandra, MDS;DNB;PhD, 9908183071, viswachandra@hotmail.com
About this study
Official title: Clinical Effects of a Single Application of a Novel Photosensitizer in The Treatment of Chronic Periodontitis - A Randomized Controlled Trial
The aim of this study is to evaluate the periodontal outcomes after applying antimicrobial photodynamic therapy with a novel photosensitizer as compared to LASER assisted scaling and root planing alone.
Read the detailed description
LASER assisted SRP followed by antimicrobial photodynamic therapy with a novel photosensitizer dye Phthalocyanine will be done in test group subjects.
- Conditions
- Periodontitis, Alveolar Bone Loss
- Being tested
- Phthalocyanine Dye, LASER assisted SRP
- Medical subject headings
- Periodontitis, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phthalocyanine DyeDrug
Also called Experimental group
following LASER assisted SRP, a novel photosensitizer phthalocyanine dye will be placed
LASER assisted SRPDrug
Also called Control group
LASER assisted SRP will be carried
| Study group | Role | What they receive |
|---|---|---|
| main treatment group | Experimental | LASER assisted SRP followed by antimicrobial photodynamic therapy with a novel photosensitizer dye Phthalocyanine Receives: Drug: Phthalocyanine Dye; Drug: LASER assisted SRP |
| control group | Placebo comparator | LASER assisted SRP Receives: Drug: LASER assisted SRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Release profile of the drug
Release profile of the drug in Gingival Crevicular Fluid (GCF) samples will be evaluated through biochemical testing kits.
Measured: Change from baseline to 7-days.
probing pocket depths (PPD)
Assessment of probing pocket depths (PPD, in mm) by using a manual periodontal probe on six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual and distolingual) will be performed.
Measured: Change from baseline to 6-months.
clinical attachment level (CAL)
Assessment of clinical attachment level (CAL, in mm) by using a manual periodontal probe on six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual and distolingual) will be performed.
Measured: Change from baseline to 6-months.
Secondary outcomes (2)
plaque index (PI)
Assessment of plaque (PI) - according to Turesky modification of Quigley and Hein Plaque Index; 0-No plaque 1-Isolated flecks of plaque at the gingival margin 2-A continuous band of plaque up to 1mm at the gingival margin 3-Plaque greater than 1mm in width and covering up to one third of the tooth surface 4-Plaque covering from one thirds to two thirds of the tooth surface 5-Plaque covering more than two thirds of the tooth surface.
Measured: Change from baseline to 6-months.
bleeding on probing (BOP)
Assessment of bleeding on probing (BOP) as a dichotomous variable ("Yes"/"No") by using a manual periodontal probe.
Measured: Change from baseline to 6-months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Jun 2019
- Primary completionNov 2020 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SVS Institute of Dental Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr R Viswa Chandra, SVS Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374383
- Sponsor's protocol ID
- SVSIDS/PERIO/2/2019
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 7 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of a Single Application of a Novel Photosensitizer in The Treatment of Chronic Periodontitis - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04374383
- Acronym / sponsor ID
- SVSIDS/PERIO/2/2019
- Conditions
- Periodontitis, Alveolar Bone Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- SVS Institute of Dental SciencesUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 5 May 2020 (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 aim of this study is to evaluate the periodontal outcomes after applying antimicrobial photodynamic therapy with a novel photosensitizer as compared to LASER assisted scaling and root planing alone.
Detailed description
LASER assisted SRP followed by antimicrobial photodynamic therapy with a novel photosensitizer dye Phthalocyanine will be done in test group subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| main treatment group | Experimental | Drug: Phthalocyanine Dye, Drug: LASER assisted SRPLASER assisted SRP followed by antimicrobial photodynamic therapy with a novel photosensitizer dye Phthalocyanine |
| control group | Placebo comparator | Drug: LASER assisted SRPLASER assisted SRP |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Systemically healthy male and female patients of age 30-60 years with generalized probing pocket depths (PPD) indicative of chronic periodontitis and with atleast two sites with PPD ≥5mm in each quadrant
Key exclusion criteria (1 listed)
- Medically compromised patients, Subjects with a history of periodontal intervention within 6 months of the commencement of the study and smokers
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 |
|---|---|---|
| Phthalocyanine DyeAlso: Experimental groupfollowing LASER assisted SRP, a novel photosensitizer phthalocyanine dye will be placed | Drug | main treatment group |
| LASER assisted SRPAlso: Control groupLASER assisted SRP will be carried | Drug | control group, main treatment group |
Primary outcome
Release profile of the drug
Time frame: Change from baseline to 7-days.
Release profile of the drug in Gingival Crevicular Fluid (GCF) samples will be evaluated through biochemical testing kits.
probing pocket depths (PPD)
Time frame: Change from baseline to 6-months.
Assessment of probing pocket depths (PPD, in mm) by using a manual periodontal probe on six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual and distolingual) will be performed.
clinical attachment level (CAL)
Time frame: Change from baseline to 6-months.
Assessment of clinical attachment level (CAL, in mm) by using a manual periodontal probe on six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual and distolingual) will be performed.
2 secondary outcomes
plaque index (PI)
Time frame: Change from baseline to 6-months.
bleeding on probing (BOP)
Time frame: Change from baseline to 6-months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Phthalocyanine Dye and LASER assisted SRP in people with Periodontitis and Alveolar Bone Loss, run by SVS Institute of Dental Sciences at 2 sites in India.
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 1 inclusion and 1 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 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact RVchandra, MDS; DNB (9908183071, viswachandra@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Release profile of the drug (time frame: Change from baseline to 7-days.). The study lists 3 primary outcomes in all. 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 7 May 2020.