Periodontal DiseasesNCT06624241
Effectiveness of SRP+ Lipo-curcumin Gel for the Treatment of Stage III Periodontitis.
A study testing Lipo-Curcumin gel + SRP, Lipo gel + SRP and Discharged Gel + SRP in people with Periodontal Diseases and Periodontal Pocket, run by G. d'Annunzio University at 1 site in Italy.
Trial summary
The aim of the present study is to clinically and radiographically compare the effectivness of Scaling and Root Plannig (SRP) in association with lipo-curcumin gel (LC) respect SRP+ lipo-gel (L), SRP+ discharged (D) gel and SRP alone. This study will be designed as a randomized clinical trial of 12-month duration. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Periodontal Pocket, Periodontal Attachment Loss
- What is being tested?
- Lipo-Curcumin gel + SRP, Lipo gel + SRP and Discharged Gel + SRP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jun 2024to Sep 2025
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of periodontitis stage III (grades A to C)
- on-smokers or former smokers who quit at least 1 year ago, and had not received any periodontal treatment in the 3 months prior to recruitment
- FMPS < 20% at baseline
- Furcation not involved
- Not Pregnant or Lactating
- Signed informed consent
Who cannot join
- Presence of uncontrolled systemic diseases that could affect treatment outcomes such as diabetes mellitus with an HbA1C>7%, rheumatoid arthritis or any form of immunosuppression
- Patients that had received systemic or local delivery of antibiotic therapy 6 weeks before enrollment
- Chronic intake of NSAIDs or steroids, currently
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
G. d'Annunzio University
Chieti, CH, 66100
About this study
Official title: Clinical Evaluation of Lipo-Curcumin Gel in Association with SRP for the Treatment of Stage III Periodontitis: a Randomized and Controlled Clinical Trial.
The aim of the present study is to clinically and radiographically compare the effectivness of Scaling and Root Plannig (SRP) in association with lipo-curcumin gel (LC) respect SRP+ lipo-gel (L), SRP+ discharged (D) gel and SRP alone.
This study will be designed as a randomized clinical trial of 12-month duration. A total of 40 patients will be recruited and randomly equally distributed into 4 groups: an experimental group treated with SRP + LC, a first control group treated with SRP + L, a second control group treated with SRP+D and a third control group SRP alone.
Read more
Each defect will be treated with an ultrasonic scaler with dedicated thin tips for supra- and subgingival debridement associated with hand instrumentation under local anesthesia. Caution will be taken to preserve the stability of soft tissues. Following SRP, experimental and control sites will be randomly chosen. The test sites will be t filled with a Lipo-Curcumin gel and sealed with cyanoacrylate. In the first control group the defects will be be filled with a Lipo gel and sealed with cyanoacrylate. In the second control sites he pocket defect will be filled with a discharged gel and sealed with cyanoacrylate, in the third control group SRP alone will be performed.
Pre- and post-treatment clinical measurements were performed by an examiner blinded to the treatment modalities using a graded periodontal probe (HuFriedy UNC 15). Before the treatment and at 6 and 12 months post-treatment, all patients were examined by measuring the clinical attachment level, probing depth, gingival recession, full-mouth plaque score and bleeding on probing.
- Being tested
- Lipo-Curcumin gel + SRP, Lipo gel + SRP, Discharged Gel + SRP, SRP alone
- Keywords
- Curcumin, SRP, Liposome, Periodontitis
- Medical subject headings
- Periodontal Diseases, Periodontal Pocket, Periodontal Attachment Loss, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipo-Curcumin gel + SRPProcedure or surgery
The pocket defect will be debrided with the use of fine ultrasonic tips and mini hand instruments and will be treated with the application of Lipo- Curcumin gel. The pocket will be sealed with cyanoacrylate.
Lipo gel + SRPProcedure or surgery
The pocket defect will be debrided with the use of fine ultrasonic tips and mini hand instruments and will be treated with the application of Lipo gel. The pocket will be sealed with cyanoacrylate.
Discharged Gel + SRPProcedure or surgery
The pocket defect will be debrided with the use of fine ultrasonic tips and mini hand instruments and will be treated with the application of discharged gel. The pocket will be sealed with cyanoacrylate.
SRP aloneProcedure or surgery
The pocket defect will only be debrided with the use of fine ultrasound tips and mini hand instruments and no further treatment will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Lipo-Curcumin gel + SRP | Experimental | After SRP the pocket defect will be filled with a Lipo-Curcumin gel and sealed with cyanoacrylate. Receives: Procedure: Lipo-Curcumin gel + SRP |
| Lipo gel + SRP | Active comparator | After SRP the pocket defect will be filled with a Lipo gel and sealed with cyanoacrylate Receives: Procedure: Lipo gel + SRP |
| Discharged Gel + SRP | Active comparator | After SRP the pocket defect will be filled with a discharged gel and sealed with cyanoacrylate Receives: Procedure: Discharged Gel + SRP |
| SRP alone | Active comparator | SRP alone will be performed. Receives: Procedure: SRP alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket Probing Depth (PPD)
Distance between the gingival margin and the bottom of the pocket.
Measured: 12 months
Secondary outcomes (4)
Clinical Attachment Level (CAL)
Distance between the CEJ and the bottom of the pocket
Measured: 12 months
Gingival Recession (GR)
Distance between the CEJ and the gingival margin.
Measured: 12 months
Full Mouth Plaque Score
Index that evaluates the general presence of bacterial plaque for all teeth. Through the passage of the probe, the presence of plaque deposits is reported for 4 surfaces for each tooth. A ratio is made between the contaminated surfaces and the total surfaces investigated to obtain a percentage value.
Measured: 12 months
Full Mouth Bleeding Score
Index that evaluates the general presence of bleeding for all teeth. Through the insertion of a periodontal probe, the presence of bleeding on probing is signaled for 4 sites for each tooth. A ratio is made between the bleeding sites and the total sites investigated to obtain a percentage value.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start12 Jun 2024
- Primary completionJun 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Paolantonio, G. d'Annunzio University
- Investigators
- Michele Paolantonio, DDS, MD, Study chair, University 'G. D'Annunzio' of Chieti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624241
- Sponsor's protocol ID
- 12062024
- Status last verified
- Jun 2024
- First submitted
- 30 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Lipo-Curcumin Gel in Association with SRP for the Treatment of Stage III Periodontitis: a Randomized and Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06624241
- Acronym / sponsor ID
- 12062024
- Keywords
- Curcumin, SRP, Liposome, Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 2 Oct 2024 (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 the present study is to clinically and radiographically compare the effectivness of Scaling and Root Plannig (SRP) in association with lipo-curcumin gel (LC) respect SRP+ lipo-gel (L), SRP+ discharged (D) gel and SRP alone.
This study will be designed as a randomized clinical trial of 12-month duration. A total of 40 patients will be recruited and randomly equally distributed into 4 groups: an experimental group treated with SRP + LC, a first control group treated with SRP + L, a second control group treated with SRP+D and a third control group SRP alone.
Each defect will be treated with an ultrasonic scaler with dedicated thin tips for supra- and subgingival debridement associated with hand instrumentation under local anesthesia. Caution will be taken to preserve the stability of soft tissues. Following SRP, experimental and control sites will be randomly chosen. The test sites will be t filled with a Lipo-Curcumin gel and sealed with cyanoacrylate. In the first control group the defects will be be filled with a Lipo gel and sealed with cyanoacrylate. In the second control sites he pocket defect will be filled with a discharged gel and sealed with cyanoacrylate, in the third control group SRP alone will be performed.
Pre- and post-treatment clinical measurements were performed by an examiner blinded to the treatment modalities using a graded periodontal probe (HuFriedy UNC 15). Before the treatment and at 6 and 12 months post-treatment, all patients were examined by measuring the clinical attachment level, probing depth, gingival recession, full-mouth plaque score and bleeding on probing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lipo-Curcumin gel + SRP | Experimental | Procedure: Lipo-Curcumin gel + SRPAfter SRP the pocket defect will be filled with a Lipo-Curcumin gel and sealed with cyanoacrylate. |
| Lipo gel + SRP | Active comparator | Procedure: Lipo gel + SRPAfter SRP the pocket defect will be filled with a Lipo gel and sealed with cyanoacrylate |
| Discharged Gel + SRP | Active comparator | Procedure: Discharged Gel + SRPAfter SRP the pocket defect will be filled with a discharged gel and sealed with cyanoacrylate |
| SRP alone | Active comparator | Procedure: SRP aloneSRP alone will be performed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a diagnosis of periodontitis stage III (grades A to C)
- on-smokers or former smokers who quit at least 1 year ago, and had not received any periodontal treatment in the 3 months prior to recruitment
- FMPS < 20% at baseline
- Furcation not involved
- Not Pregnant or Lactating
Key exclusion criteria (3 listed)
- Presence of uncontrolled systemic diseases that could affect treatment outcomes such as diabetes mellitus with an HbA1C>7%, rheumatoid arthritis or any form of immunosuppression
- Patients that had received systemic or local delivery of antibiotic therapy 6 weeks before enrollment
- Chronic intake of NSAIDs or steroids, currently
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 |
|---|---|---|
| Lipo-Curcumin gel + SRPThe pocket defect will be debrided with the use of fine ultrasonic tips and mini hand instruments and will be treated with the application of Lipo- Curcumin gel. The pocket will be sealed with cyanoacrylate. | Procedure or surgery | Lipo-Curcumin gel + SRP |
| Lipo gel + SRPThe pocket defect will be debrided with the use of fine ultrasonic tips and mini hand instruments and will be treated with the application of Lipo gel. The pocket will be sealed with cyanoacrylate. | Procedure or surgery | Lipo gel + SRP |
| Discharged Gel + SRPThe pocket defect will be debrided with the use of fine ultrasonic tips and mini hand instruments and will be treated with the application of discharged gel. The pocket will be sealed with cyanoacrylate. | Procedure or surgery | Discharged Gel + SRP |
| SRP aloneThe pocket defect will only be debrided with the use of fine ultrasound tips and mini hand instruments and no further treatment will be performed. | Procedure or surgery | SRP alone |
Primary outcome
Pocket Probing Depth (PPD)
Time frame: 12 months
Distance between the gingival margin and the bottom of the pocket.
4 secondary outcomes
Clinical Attachment Level (CAL)
Time frame: 12 months
Gingival Recession (GR)
Time frame: 12 months
Full Mouth Plaque Score
Time frame: 12 months
Full Mouth Bleeding Score
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- 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.
Michele Paolantonio, DDS, MD study chair
University 'G. D'Annunzio' of Chieti
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipo-Curcumin gel + SRP, Lipo gel + SRP and Discharged Gel + SRP in people with Periodontal Diseases and Periodontal Pocket, run by G. d'Annunzio University at 1 site in Italy.
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 6 inclusion and 3 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 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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. 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?
Contact Michele Paolantonio, DDS, MD (3395204073, michelepaolantonio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pocket Probing Depth (PPD) (time frame: 12 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 2 Oct 2024.