PeriodontitisPhase 4NCT04964167
Indocyanine-green Mediated Photosensitizer VS Aloe Vera Gel: Adjunct Therapy to Scaling and Root Planing in Patients With Chronic Periodontitis
A Phase 4 study testing Plant extract in people with Periodontitis and Periodontal Inflammation, run by Riyadh Elm University at 2 sites in 2 countries.
Trial summary
For proving the potential of tropical medicaments on clinical parameters of periodontitis, a comprehensive assessment is required between therapeutic medicaments. The main aim of the study was to clinically evaluate and compare the efficacy of indocyanine green mediated photodynamic therapy (PDT) and aleo vera (AV)… Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Periodontal Inflammation
- What is being tested?
- Plant extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Sep 2021to 28 Feb 2022
- Phase
- Phase 4
- 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
- age of ≥ 30 years;
- ≥ 20 natural teeth; and
- chronic-periodontitis (≥ 3 mm of CAL and PD pocket depth respectively on at least 30% of dental sites).
Who cannot join
- chronic systemic diseases;
- PD therapy during last 6 months;
- habitual use of chewable and non-chewable tobacco (smoking);
- alcohol consumers; or
- use of particular medications during last three months (steroidal and non-steroidal drugs/ anti-biotic/ anti-depressants)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
For proving the potential of tropical medicaments on clinical parameters of periodontitis, a comprehensive assessment is required between therapeutic medicaments. The main aim of the study was to clinically evaluate and compare the efficacy of indocyanine green mediated photodynamic therapy (PDT) and aleo vera (AV) extract when used as an adjunct therapy to scaling and root planning (SRP) for treatment of chronic periodontitis.
One hundred and fifty patients included in this study were randomly distributed in three treatment groups Group I (SRP), Group II (SRP+PDT) and Group III (SRP+AV). Four clinical parameters plaque index (PI), bleeding on probing (BoP), periodontal (PD) pocket depth and clinical attachment level (CAL) were evaluated at three time points baseline, 3rd and 6th month respectively. Additionally the amount of three inflammatory cytokines IL-6, IL-8 and TNF- α in gingival crevicular fluid (GCF) was identified using enzyme linked immune-sorbent assay (ELISA) technique.
- Conditions
- Periodontitis, Periodontal Inflammation
- Being tested
- Plant extract
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant extractCombination product
Also called Aloe Vera
Natural plant extract
| Study group | Role | What they receive |
|---|---|---|
| Group I (Standard Root Planning) | Placebo comparator | Not described Receives: Combination Product: Plant extract |
| Group II (Standard Root Planning + Photodynamic Therapy) | Active comparator | Not described Receives: Combination Product: Plant extract |
| Group III (Standard Root Planning + Aloe Vera) | Experimental | Not described Receives: Combination Product: Plant extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically Evaluating the Effects of Topical Indocyanine-green Mediated Photosensitizer VS Aloe vera Gel: Adjunct therapy to Scaling and Root Planing in Patients with Chronic Periodontitis
Adjunct treatment regimens PDT and AV extract significantly helped in plummeting inflammation of PD tissue
Measured: 9 months
IL-6 concentration in pg/ml
Identify the concentration of IL-6 in the gingival crevicular fluid
Measured: 6 months
IL-8 concentration in pg/ml
Identify the concentration of IL-8 in the gingival crevicular fluid
Measured: 6 months
TNF-α levels in pg/ml
Identify the concentration of TNF-α in the gingival crevicular fluid
Measured: 6 months
Periodontal pocket depth in mm
Periodontal pocket depth
Measured: 6 months
Clinical attachment loss in mm
Periodontal attachment loss
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start7 Sep 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riyadh Elm University
- Sponsor type
- University, hospital or other
- Collaborators
- Salah Abdalkreem Almohana, Abdulmohsen Khalid Alanazi, Abdulelah Khalid Alanazi, Alhanouf Abdulkarem Almohana
- Responsible party
- Principal investigator, Zeeshan Qamar, Riyadh Elm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964167
- Sponsor's protocol ID
- FIRP/2021/94
- Status last verified
- Sep 2023
- First submitted
- 28 Jun 2021
- Last updated
- 13 Sep 2023
- 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 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indocyanine-green Mediated Photosensitizer VS Aloe Vera Gel: Adjunct Therapy to Scaling and Root Planing in Patients With Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT04964167
- Acronym / sponsor ID
- FIRP/2021/94
- Conditions
- Periodontitis, Periodontal Inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Riyadh Elm UniversityUniversity, hospital or other
- Collaborators
- Salah Abdalkreem Almohana, Abdulmohsen Khalid Alanazi, Abdulelah Khalid Alanazi, Alhanouf Abdulkarem Almohana
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 15 Jul 2021 (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.
For proving the potential of tropical medicaments on clinical parameters of periodontitis, a comprehensive assessment is required between therapeutic medicaments. The main aim of the study was to clinically evaluate and compare the efficacy of indocyanine green mediated photodynamic therapy (PDT) and aleo vera (AV) extract when used as an adjunct therapy to scaling and root planning (SRP) for treatment of chronic periodontitis.
One hundred and fifty patients included in this study were randomly distributed in three treatment groups Group I (SRP), Group II (SRP+PDT) and Group III (SRP+AV). Four clinical parameters plaque index (PI), bleeding on probing (BoP), periodontal (PD) pocket depth and clinical attachment level (CAL) were evaluated at three time points baseline, 3rd and 6th month respectively. Additionally the amount of three inflammatory cytokines IL-6, IL-8 and TNF- α in gingival crevicular fluid (GCF) was identified using enzyme linked immune-sorbent assay (ELISA) technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (Standard Root Planning) | Placebo comparator | Combination Product: Plant extract |
| Group II (Standard Root Planning + Photodynamic Therapy) | Active comparator | Combination Product: Plant extract |
| Group III (Standard Root Planning + Aloe Vera) | Experimental | Combination Product: Plant extract |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age of ≥ 30 years;
- ≥ 20 natural teeth; and
- chronic-periodontitis (≥ 3 mm of CAL and PD pocket depth respectively on at least 30% of dental sites).
Key exclusion criteria (5 listed)
- chronic systemic diseases;
- PD therapy during last 6 months;
- habitual use of chewable and non-chewable tobacco (smoking);
- alcohol consumers; or
- use of particular medications during last three months (steroidal and non-steroidal drugs/ anti-biotic/ anti-depressants)
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 |
|---|---|---|
| Plant extractAlso: Aloe VeraNatural plant extract | Combination product | Group I (Standard Root Planning), Group II (Standard Root Planning + Photodynamic Therapy), Group III (Standard Root Planning + Aloe Vera) |
Primary outcome
Clinically Evaluating the Effects of Topical Indocyanine-green Mediated Photosensitizer VS Aloe vera Gel: Adjunct therapy to Scaling and Root Planing in Patients with Chronic Periodontitis
Time frame: 9 months
Adjunct treatment regimens PDT and AV extract significantly helped in plummeting inflammation of PD tissue
IL-6 concentration in pg/ml
Time frame: 6 months
Identify the concentration of IL-6 in the gingival crevicular fluid
IL-8 concentration in pg/ml
Time frame: 6 months
Identify the concentration of IL-8 in the gingival crevicular fluid
TNF-α levels in pg/ml
Time frame: 6 months
Identify the concentration of TNF-α in the gingival crevicular fluid
Periodontal pocket depth in mm
Time frame: 6 months
Periodontal pocket depth
Clinical attachment loss in mm
Time frame: 6 months
Periodontal attachment loss
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Plant extract in people with Periodontitis and Periodontal Inflammation, run by Riyadh Elm University at 2 sites in 2 countries.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 13 Sep 2023. 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 Pakistan, Saudi Arabia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinically Evaluating the Effects of Topical Indocyanine-green Mediated Photosensitizer VS Aloe vera Gel: Adjunct therapy to Scaling and Root Planing in Patients with Chronic Periodontitis (time frame: 9 months). The study lists 6 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 13 Sep 2023.