Diabetes MellitusPhase 4NCT02437747
Locally Delivered Aloe Vera Gel in the Treatment of Chronic Periodontitis Patients With Diabetes Mellitus
A Phase 4 study testing SRP + Aloe and SRP in people with Diabetes Mellitus and Chronic Periodontitis, run by Dr. D. Y. Patil Dental College & Hospital.
Trial summary
A study on the effect of locally delivered aloe vera gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis patients with controlled type II diabetes mellitus.The evaluation of Plaque Index, Gingival Index, Probing Pocket Depth, Relative Attachment Level at baseline, 6 weeks and 3… Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Diabetes Mellitus, Chronic Periodontitis
- What is being tested?
- SRP + Aloe and SRP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Mar 2015
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients age 30 - 55 years from both genders.
- Patients with controlled Type II Diabetes Mellitus (HbA1c < 7%) with Chronic periodontitis having ≥ 5mm periodontal pockets bilaterally atleast in one site.
- Patients on oral hypoglycaemic agents.
- Subjects who have not received periodontal therapy within preceding 6 months.
- Patients willing to comply with all study related procedures.
Who cannot join
- Subjects who have received antibiotic treatment in the preceding 3 months.
- History of prolonged use of antibiotics/ steroids/ immunosuppressive agents /aspirin/ anticoagulants/ other medications including any other herbal products.
- Pregnant or lactating women.
- Smokers.
- History of systemic diseases like hypertension, HIV, bone metabolic disorders, radiation therapy, Osteoporosis, immunosuppressive therapy, cancer etc.other than Diabetes.
- Unwilling patients
About this study
Official title: Local Drug Delivery of Aloe Vera Gel in Chronic Periodontitis Patients With Controlled Diabetes Mellitus
A study on the effect of locally delivered aloe vera gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis patients with controlled type II diabetes mellitus.The evaluation of Plaque Index, Gingival Index, Probing Pocket Depth, Relative Attachment Level at baseline, 6 weeks and 3 months and Glycosylated heamoglobin at baseline and 3 months.
Read the detailed description
Aloe vera gel was locally delivered in the periodontal pockets of ≥ 5mm bilaterally in chronic periodontitis patients with diabetes under control.(HbA1c-6.6-8.6%).The study design had two groups-one in which scaling and root planing and local delivery of aloe vera gel and the other only scaling and root planing.
The evaluation of clinical parameters of PI, GI, PPD and RAL at baseline, 6 weeks and 3 months.
HbA1c evaluated at baseline and 3 months.
- Conditions
- Diabetes Mellitus, Chronic Periodontitis
- Being tested
- SRP + Aloe, SRP
- Keywords
- clinical trial
- Medical subject headings
- Diabetes Mellitus, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRP + AloeDrug
Also called Korphad Ghar
Scaling and root planing along with aloe vera application was done
SRPProcedure or surgery
Scaling and root planing was done
| Study group | Role | What they receive |
|---|---|---|
| SRP+ Aloe Group | Experimental | Scaling and root planing was done along with application of aloe vera gel as an adjunct in selected sites. Receives: Drug: SRP + Aloe |
| SRP Group | Sham comparator | Only scaling and root planing was done on the opposite side. Receives: Procedure: SRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical parameter of probing pocket depth
Clinically change in the probing pocket depth.
Measured: 3 months
Secondary outcomes (4)
Glycosylated haemoglobin
HbA1c levels evaluated at baseline and 3 months
Measured: 3 months
Clinical parameter of plaque index
Change in the plaque index.
Measured: 3 months
Clinical parameter of gingival index
Change in the gingival index.
Measured: 3 months
Clinical parameter of relative attachment level
Change in the relative attachment level.
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 posted8 May 2015 (estimated)
- Study startJun 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. D. Y. Patil Dental College & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gurbani Kaur, Dr. D. Y. Patil Dental College & Hospital
- Investigators
- Archana Singh, MDS, Study director, Dr.D.Y.Patil Vidyapeeth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437747
- Sponsor's protocol ID
- DPU/431(7) /2014
- Status last verified
- May 2015
- First submitted
- 29 Apr 2015
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Drug Delivery of Aloe Vera Gel in Chronic Periodontitis Patients With Controlled Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02437747
- Acronym / sponsor ID
- DPU/431(7) /2014
- Conditions
- Diabetes Mellitus, Chronic Periodontitis
- Keywords
- clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Dr. D. Y. Patil Dental College & HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 May 2015 (estimated)
- 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.
A study on the effect of locally delivered aloe vera gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis patients with controlled type II diabetes mellitus.The evaluation of Plaque Index, Gingival Index, Probing Pocket Depth, Relative Attachment Level at baseline, 6 weeks and 3 months and Glycosylated heamoglobin at baseline and 3 months.
Detailed description
Aloe vera gel was locally delivered in the periodontal pockets of ≥ 5mm bilaterally in chronic periodontitis patients with diabetes under control.(HbA1c-6.6-8.6%).The study design had two groups-one in which scaling and root planing and local delivery of aloe vera gel and the other only scaling and root planing.
The evaluation of clinical parameters of PI, GI, PPD and RAL at baseline, 6 weeks and 3 months.
HbA1c evaluated at baseline and 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SRP+ Aloe Group | Experimental | Drug: SRP + AloeScaling and root planing was done along with application of aloe vera gel as an adjunct in selected sites. |
| SRP Group | Sham comparator | Procedure: SRPOnly scaling and root planing was done on the opposite side. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients age 30 - 55 years from both genders.
- Patients with controlled Type II Diabetes Mellitus (HbA1c < 7%) with Chronic periodontitis having ≥ 5mm periodontal pockets bilaterally atleast in one site.
- Patients on oral hypoglycaemic agents.
- Subjects who have not received periodontal therapy within preceding 6 months.
- Patients willing to comply with all study related procedures.
Key exclusion criteria (6 listed)
- Subjects who have received antibiotic treatment in the preceding 3 months.
- History of prolonged use of antibiotics/ steroids/ immunosuppressive agents /aspirin/ anticoagulants/ other medications including any other herbal products.
- Pregnant or lactating women.
- Smokers.
- History of systemic diseases like hypertension, HIV, bone metabolic disorders, radiation therapy, Osteoporosis, immunosuppressive therapy, cancer etc.other than Diabetes.
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 |
|---|---|---|
| SRP + AloeAlso: Korphad GharScaling and root planing along with aloe vera application was done | Drug | SRP+ Aloe Group |
| SRPScaling and root planing was done | Procedure or surgery | SRP Group |
Primary outcome
Clinical parameter of probing pocket depth
Time frame: 3 months
Clinically change in the probing pocket depth.
4 secondary outcomes
Glycosylated haemoglobin
Time frame: 3 months
Clinical parameter of plaque index
Time frame: 3 months
Clinical parameter of gingival index
Time frame: 3 months
Clinical parameter of relative attachment level
Time frame: 3 months
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 8 May 2015.
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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.
Archana Singh, MDS study director
Dr.D.Y.Patil Vidyapeeth
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SRP + Aloe and SRP in people with Diabetes Mellitus and Chronic Periodontitis, run by Dr. D. Y. Patil Dental College & Hospital.
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 5 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: finished, as of the sponsor's last update on 8 May 2015. 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.
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?
Clinical parameter of probing pocket depth (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 8 May 2015.