Chronic PeriodontitisPhase 1/2NCT03203746
Gingival Crevicular Fluid Levels of Protein Carbonyl Following the Use of Lycopene in Chronic Periodontitis
A Phase 1/2 study testing Lycopene + SRP and SRP only in people with Chronic Periodontitis, run by Maie Sami tawfik.
Trial summary
Effect of Locally Delivered Antioxidants as An Adjunct to Non-surgical Periodontal Therapy on GCF Level of Oxidative Stress Marker; Protein Carbonyl Read more about this study
- Who is it for?
- Ages 35 to 52 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Lycopene + SRP and SRP only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 28 Sep 2015to 14 Dec 2016
- Phase
- Phase 1/2
- 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 35 to 52 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All subjects were free from any systemic diseases.
- Subjects for group I and II were suffering from severe chronic periodontitis (Armitage et al., 1999).
- Group III included subjects with clinically healthy periodontium.
- All subjects were between 35-60 years old.
- Both genders were included.
- Subjects were able to return for follow up visits.
- Subjects agreed to sign a written consent after the nature of the study was explained.
Who cannot join
- History of scaling and root planing or periodontal surgery < 6 months prior to initiation of the study.
- History of administration of antimicrobial drugs or over the counter antioxidants like Vit C, Vit B, β-carotene < 6 months prior to the baseline examination.
- Subjects who reported any side effects or drug allergies from antioxidants.
- Subjects with mobile teeth, abscesses and defected restorations related to the affected sites.
- Subjects with para-functional habits.
- Pregnant and lactating females.
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- Smokers, alcoholic and drug abusers.
- Prisoner.
- Mentally retarded patients.
About this study
Official title: Gingival Crevicular Fluid Levels of Protein Carbonyl Oxidative Stress Biomarker Following the Use of Locally Delivered Lycopene Antioxidants in Patients With Chronic Periodontitis - Randomized Clinical Trial
Effect of Locally Delivered Antioxidants as An Adjunct to Non-surgical Periodontal Therapy on GCF Level of Oxidative Stress Marker; Protein Carbonyl
Read the detailed description
The study was designed as a randomized controlled clinical trial. Total subjects selected were allocated into three study groups, Group I (Test group), Group II (Positive control group) and Group III (Negative control group). Group I: Included 8 patients with severe chronic periodontitis managed by Scaling and root planing and local delivery of lycopene loaded in solid lipid microparticles. Group II: Included 8 patients with severe chronic periodontitis managed by Scaling and root planing only. Group III: Included 8 patients with clinically healthy periodontium.
Protein carbonyl biomarker level and clinical parameters were assisted to evaluate the effect of lycopene as an adjunct to scaling and root planing.
- Conditions
- Chronic Periodontitis
- Being tested
- Lycopene + SRP, SRP only
- Keywords
- Lycopene, Chronic periodontitis, Protein carbonyl
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lycopene + SRPDrug
SRP onlyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group I: Lycopene + SRP | Experimental | Lycopene, 0.1 ml injected once in the periodontal pocket after scaling and root planing Receives: Drug: Lycopene + SRP |
| Group II: SRP only | Active comparator | Scaling and root planing only without lycopene Receives: Procedure: SRP only |
| Group III: healthy subjects | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
GCF level of protein carbonyl
to assess GCF level of protein carbonyl following local delivery of sustained release form of lycopene as an adjunct to scaling and root planning (SRP) in management of severe chronic periodontitis patients.
Measured: 1 month
Secondary outcomes (6)
Plaque index
To assess changes in plaque index following local delivery of stained release form of lycopene.
Measured: 6 months
Modified gingival index
to assess changes in the gingival index following local delivery of sustained release form of lycopene.
Measured: 6 months
Probing depth
To assess probing depth following local delivery of stained release form of lycopene.
Measured: 6 months
Clinical attachment loss
To assess clinical attachment loss following local delivery of sustained release form of lycopene.
Measured: 6 minths
Radiographic changes
to assess radiographic changes in the infrabony defects following local delivery of sustained release form of lycopene.
Measured: 6 months
Drug release
to assess rate of lycopene release using high performance liquid chromatography technique (HPLC).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start28 Sep 2015
- Primary completion10 Nov 2016
- Study completion14 Dec 2016
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Total subjects selected were allocated into three study groups, Group I (Test group), Group II (Positive control group) and Group III (Negative control group). Group I: Included 8 patients with severe chronic periodontitis managed by Scaling and root planing (SRP) and local delivery of lycopene loaded in solid lipid microparticles. Group II: Included 8 patients with severe chronic periodontitis managed by Scaling and root planing (SRP) only. Group III: Included 8 patients with clinically healthy periodontium.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maie Sami tawfik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maie Sami tawfik, Ain Shams University
- Investigators
- Ahmed Y Gamal, PhD, Study director, AinShams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203746
- Sponsor's protocol ID
- Maie Sami
- Status last verified
- Jun 2017
- First submitted
- 24 Jun 2017
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Crevicular Fluid Levels of Protein Carbonyl Oxidative Stress Biomarker Following the Use of Locally Delivered Lycopene Antioxidants in Patients With Chronic Periodontitis - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03203746
- Acronym / sponsor ID
- Maie Sami
- Conditions
- Chronic Periodontitis
- Keywords
- Lycopene, Chronic periodontitis, Protein carbonyl
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Maie Sami tawfikUniversity, hospital or other
- Study start
- 28 Sep 2015 (actual)
- Primary completion
- 10 Nov 2016 (actual)
- Study completion
- 14 Dec 2016 (actual)
- First posted
- 29 Jun 2017 (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.
Effect of Locally Delivered Antioxidants as An Adjunct to Non-surgical Periodontal Therapy on GCF Level of Oxidative Stress Marker; Protein Carbonyl
Detailed description
The study was designed as a randomized controlled clinical trial. Total subjects selected were allocated into three study groups, Group I (Test group), Group II (Positive control group) and Group III (Negative control group). Group I: Included 8 patients with severe chronic periodontitis managed by Scaling and root planing and local delivery of lycopene loaded in solid lipid microparticles. Group II: Included 8 patients with severe chronic periodontitis managed by Scaling and root planing only. Group III: Included 8 patients with clinically healthy periodontium.
Protein carbonyl biomarker level and clinical parameters were assisted to evaluate the effect of lycopene as an adjunct to scaling and root planing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Total subjects selected were allocated into three study groups, Group I (Test group), Group II (Positive control group) and Group III (Negative control group). Group I: Included 8 patients with severe chronic periodontitis managed by Scaling and root planing (SRP) and local delivery of lycopene loaded in solid lipid microparticles. Group II: Included 8 patients with severe chronic periodontitis managed by Scaling and root planing (SRP) only. Group III: Included 8 patients with clinically healthy periodontium.
| Arm | Type | Receives |
|---|---|---|
| Group I: Lycopene + SRP | Experimental | Drug: Lycopene + SRPLycopene, 0.1 ml injected once in the periodontal pocket after scaling and root planing |
| Group II: SRP only | Active comparator | Procedure: SRP onlyScaling and root planing only without lycopene |
| Group III: healthy subjects | No intervention | –No intervention |
Who may qualify
- Ages
- 35 to 52 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- All subjects were free from any systemic diseases.
- Subjects for group I and II were suffering from severe chronic periodontitis (Armitage et al., 1999).
- Group III included subjects with clinically healthy periodontium.
- All subjects were between 35-60 years old.
- Both genders were included.
Key exclusion criteria (9 listed)
- History of scaling and root planing or periodontal surgery < 6 months prior to initiation of the study.
- History of administration of antimicrobial drugs or over the counter antioxidants like Vit C, Vit B, β-carotene < 6 months prior to the baseline examination.
- Subjects who reported any side effects or drug allergies from antioxidants.
- Subjects with mobile teeth, abscesses and defected restorations related to the affected sites.
- Subjects with para-functional habits.
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 |
|---|---|---|
| Lycopene + SRP | Drug | Group I: Lycopene + SRP |
| SRP only | Procedure or surgery | Group II: SRP only |
Primary outcome
GCF level of protein carbonyl
Time frame: 1 month
to assess GCF level of protein carbonyl following local delivery of sustained release form of lycopene as an adjunct to scaling and root planning (SRP) in management of severe chronic periodontitis patients.
6 secondary outcomes
Plaque index
Time frame: 6 months
Modified gingival index
Time frame: 6 months
Probing depth
Time frame: 6 months
Clinical attachment loss
Time frame: 6 minths
Radiographic changes
Time frame: 6 months
Drug release
Time frame: 1 month
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 29 Jun 2017.
- 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.
Ahmed Y Gamal, PhD study director
AinShams university
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lycopene + SRP and SRP only in people with Chronic Periodontitis, run by Maie Sami tawfik.
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 7 inclusion and 9 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 29 Jun 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
GCF level of protein carbonyl (time frame: 1 month). 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 29 Jun 2017.