Clinical trial NCT03203746: Gingival Crevicular Fluid Levels of Protein Carbonyl Following the Use of Lycopene in Chronic Periodontitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Periodontitis
Keywords: Lycopene
Chronic periodontitis
Protein carbonyl
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 24
Sex: ALL
Minimum age (years): 35
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Smokers, alcoholic and drug abusers.
* Prisoner.
* Mentally retarded patients.

Primary outcomes:
measure: GCF level of protein carbonyl
timeFrame: 1 month
Secondary outcomes:
measure: Plaque index
timeFrame: 6 months
measure: Modified gingival index
timeFrame: 6 months
measure: Probing depth
timeFrame: 6 months
measure: Clinical attachment loss
timeFrame: 6 minths
measure: Radiographic changes
timeFrame: 6 months
measure: Drug release
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: AinShams university
name: Ahmed Y Gamal, PhD
role: STUDY_DIRECTOR
References: