Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05861206
Other study ID # RecepTayyipErdoganU.1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date December 23, 2022

Study information

Verified date May 2023
Source Recep Tayyip Erdogan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background and objective: Tea is the second most consumed drink in the world after water. Gingivitis is among the most common infectious diseases. In this clinical study, Chlorhexidine Gluconate (CHX) was chosen as the positive control group and the clinical and biochemical efficacy of mouthwashes with green tea, white tea and essential oil (EO) as the active ingredients were aimed to be examined comprehensively. Methods: 112 participants with gingivitis were randomly assigned to 4 different groups that different mouthwashes were used for 4 weeks. CHX-MW group (0.12% CHX, as a positive control group), EO-MW group (Listerine), GT-MW group (5% Green tea), and WT-MW group (5% White tea). The effects of the mouthwashes on plaque, inflammation, and dental staining were evaluated by indexed scores at the beginning and the end of the 4th week. In addition, markers related to gingival inflammation (IL-1beta, MMP-8) and oxidative stress (TOS, TAS, OSI (TOS/TAS)) were evaluated on samples from the gingival crevicular fluid.


Description:

Chronic gingivitis patients aged 18-32 years whose mechanical plaque control was supported with different mouthwashes were randomly assigned into 4 groups of 28 people each: CHX-MW group (0.12% CHX, as a positive control group), EO-MW group (Listerine mouthrinse), GT-MW group (5% Green tea), and WT-MW group (5% White tea). The inclusion criteria was as follows: presence of all primary teeth without a restoration, except the third molars; papillary bleeding index of 2 or 3 in at least 30% of papillae; no clinical attachment loss; being systemically healthy; and being normal weight according to body-mass index (BMI, 18,5-24,9 kg/m2). The exclusion criteria was as follows: usage of non steroidal analgesics or antibiotics in last 6 months; usage of fixed or removable orthodontic appliance; presence of a intraoral soft tissue pathology; mouth breathing; smoking; a physical or mental disability that could prevent daily plaque control; and usage of any mouthwash in last 6 months. All patients were given verbal and written motivational advice and modified bass brushing technique was taught on mouth models and in front of mirror. All patients were advised on brushes and toothpaste to use during the study period. Dental polishing was carried out if indicated. Subsequently, each patient was instructed to use 15 mL of the mouthwash delivered to them for 60 seconds 30 minutes after brushing in the morning and evening for a week. For the next 3 weeks, at the beginning of each week (8th, 15th and 22nd days), patients were invited to the clinic, oral hygiene instruction was repeated, and the mouthwashes to be used the following week were delivered to them. Measurement of the clinical parameters and gingival crevicular fluid sample collection Clinical measurements ve gingival crevicular fluid (GCF) sample collection was carried out on each patient at the beginning of the study and at the end of the 4th week by a periodontist who was blinded about study group assignment. Level of gingival inflammation was scored by mean of the following measurements: probing pocket depth (PPD) measured with a Williams type periodontal probe (Hu-Friedy, Chicago, Illionis, USA) on 6 different points (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual) around each tooth; plaque index (PI) ; and papillary bleeding index (PBI). In addition, the staining related to the mouthwash on the surface of the teeth and tongue was evaluated by gingival modification of the tooth staining index and tongue staining index in natural light environment. According to the tooth staining index, each tooth surface was divided into 4 separate regions and the staining intensity for each region was scored as; 0 = no staining, 1 = light staining (yellow), 2 = medium staining (brown), and 3 = intense staining (black). The staining index of the tongue was scored on the dorsal 2/3 front part of the tongue as; 0 = no staining, 1 = light staining (yellow), 2 = medium staining (brown), and 3 = intense staining (black). In the areas where two different colors were detected, the highest score was taken into account. GCF samples were collected between 09.00 and 12.00, 24 hours after clinical periodontal parameters were recorded in order not to affect the current periodontal status of the patients. The samples were taken from a total of 4 teeth that each was with the most PPD in a seperate quadrant. Care was taken not to sample a tooth with caries or restoration on it and/or neighboring teeth. Samples were obtained by following steps: Supragingival plaque found in the region before sampling was removed by sterile curette. After isolating saliva with sterile cotton roll tampons, the region was dried with an air spray for 10 seconds without mechanical trauma. Paper strips in standard sizes (Periopaper; ProFlow, Inc., Amityville, NY, USA) was placed in 1mm depth in the sulcus and GCF was collected for 30 seconds (with the orifice technique). This step was repeated to collect a sufficient amount of samples. Strips contaminated with blood and saliva were not included in the study. The volume of GCF on each paper strip was measured by electronic impedance method (Periotron 8010, Oraflow Inc., NY, USA) in μl. 8 paper strips from the same patient were placed in a single ependorf tube with 250 μl of phosphate buffer (Phosphate Buffer Saline; PBS, pH = 7.4) and isolated from external environment by wrapping with parafilm (ISOLAB, Akron, Ohio, USA). The tubes were maintained at -80 oC (Thermo Fisher Scientific, Waltham, MA, USA) until the time of analysis. Biochemical analysis IL-1beta and MMP-8 levels GCF IL-1beta and MMP-8 levels were determined in ng/ml using human-specific commercial ELISA kits (Elabscience Co, Ltd., Texas, USA).(Catalog no: H-0149 and H-1450, respectively) according to manufacturer instructions. Measurement of TOS and TAS levels and Oxsidative Stres İndex (OSI) TOS and TAS levels were determined by automatic measurement method, using kits (Rel Assay Diagnostics, Gaziantep, Turkey) that were developed by Erel The results were expressed as μmol hydrogen peroxide (H2O2) equivalent/L and μmol Trolox equivalent/L. OSI was calculated by TOS/ TAS rate in percentage [(TOS (μmol H2O2 equivalents/L) / (TAS(μmol Trolox equivalent/L)]. Statistical analysis Statistical analyses were made with the help of IBM SPSS Statistics software (SPSS Inc., Chicago, USA) The normality of distribution was tested with Shapiro Wilk test. Inter group comparisons were made applying Kruskal Wallis, Mann Whitney U test, and Bonferroni correction. Wilcoxon test was applied for time-dependent changes within the groups. Differences in the level of p<0.05 were regarded as statistically significant.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date December 23, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 32 Years
Eligibility Inclusion Criteria: - all primary teeth without a restoration, except the third molars - papillary bleeding index of 2 or 3 in at least 30% of papillae - no clinical attachment loss; being systemically healthy - being normal weight according to body-mass index Exclusion Criteria: - usage of non steroidal anlgesics or antibiotics in last 6 months - usage of fixed or removable orthodontic appliance - presence of a intraoral soft tissue pathology - mouth breathing - smoking - a physical or mental disability that could prevent daily plaque control - usage of any mouthwash in last 6 months

Study Design


Intervention

Other:
GT-MW group (5% Green tea), WT-MW group (5% White tea),EO-MW group (Listerine mouthrinse)
Subsequently, each patient was instructed to use 15 mL of the mouthwash (5% Green tea, 5% White tea or Listerine mouthrinse) delivered to them for 60 seconds 30 minutes after brushing in the morning and evening for a week. For the next 3 weeks, at the beginning of each week (8th, 15th and 22nd days), patients were invited to the clinic, oral hygiene instruction was repeated, and the mouthwashes to be used the following week were delivered to them.
CHX-MW group (0.12% CHX, as a positive control group)
Subsequently, each patient was instructed to use 15 mL of the mouthwash (0.12% CHX) delivered to them for 60 seconds 30 minutes after brushing in the morning and evening for a week. For the next 3 weeks, at the beginning of each week (8th, 15th and 22nd days), patients were invited to the clinic, oral hygiene instruction was repeated, and the mouthwashes to be used the following week were delivered to them.

Locations

Country Name City State
Turkey Yagmur Sarac Gul Rize

Sponsors (2)

Lead Sponsor Collaborator
Yagmur Saraç Gül Recep Tayyip Erdogan University Scientific Research Projects Coordinator

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Papillary bleeding index A blunt periodontal probe was carefully inserted into the gingival sulcus at the base of the papilla on the mesial aspect, then moved coronally to the papilla tip. This was repeated on the distal aspect of the same papilla. Same procedure was followed on the lingual aspect of the papillas.The intensity of any bleeding thus provoked is recorded on a 0-4scale:
Score 0:No bleeding Score I :A single discreet bleeding point appears Score 2: Several isolated bleeding points or a single fine line of blood appears Score 3:The interdental triangle fills with blood shortly after probing Score 4: Profuse bleeding occurs after probing; blood flows immediately into the marginal sulcus.
Finally, scores are collected and calculate the arithmetic mean for the mouth score.
changes of clinical findings from the beginning to 4th week
Primary Plaque index According to the tooth Plaque index, each tooth surface was divided into 6 separate regions and the plaque intensity for each region is scored as:
0 = No plaque in the gingival area.
= A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
= Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
= Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
Finally, scores are collected and calculate the arithmetic mean for the mouth score.
changes of clinical findings from the beginning to 4th week
Primary Probing pocket depth Probing pocket depth (PPD) measured with a periodontal probe on 6 different points around each tooth. PPD is known as distance between gingival margin and the base of the pocket/sulcus. By using periodontal probe 6 different points are measured. Each scores of surfaces are collected and averaged for the mouth score for PPD. changes of clinical findings from the beginning to 4th week
Primary Tooth staining index According to the tooth staining index, each tooth surface was divided into 4 separate regions and the staining intensity for each region was scored as; 0 = no staining,
= light staining (yellow),
= medium staining (brown), and
= intense staining (black). In the areas where two different colors were detected, the highest score was taken into account.
changes of clinical findings from the beginning to 4th week
Primary The staining index of the tongue The staining index of the tongue was scored on the dorsal 2/3 front part of the tongue as; 0 = no staining,
= light staining (yellow),
= medium staining (brown), and
= intense staining (black). In the areas where two different colors were detected, the highest score was taken into account.
changes of clinical findings from the beginning to 4th week
Primary Biochemical results:IL-1beta(ng/mL) IL-1beta(ng/mL), levels were determined in gingival crevicular fluid sample using human-specific commercial ELISA kits according to manufacturer instructions. changes of biochemical findings from the beginning to 4th week
Primary Biochemical results:MMP-8(ng/mL) MMP-8(ng/mL), levels were determined in gingival crevicular fluid sample using human-specific commercial ELISA kits according to manufacturer instructions. changes of biochemical findings from the beginning to 4th week
Primary Biochemical results:Total Oxidatif Status(µmol H2O2 Equiv./L) Total Oxidatif Status(TOS)(µmol H2O2 Equiv./L), levels were determined by automatic measurement method, using kits (Rel Assay Diagnostics, Gaziantep, Turkey) that were developed by Erel. The results were expressed as µmol hydrogen peroxide (H2O2) equivalent/L. changes of biochemical findings from the beginning to 4th week
Primary Biochemical results:Total Antioxidative Status(µmol Trolox. Equiv./L) Total Antioxidative Status(TAS)(µmol Trolox. Equiv./L) levels were determined by automatic measurement method, using kits (Rel Assay Diagnostics, Gaziantep, Turkey) that were developed by Erel. The results were expressed as µmol Trolox equivalent/L. changes of biochemical findings from the beginning to 4th week
Primary Biochemical results:Oxidative Stress Index[(µmol H2O2 Equiv./L)/(µmol Trolox. Equiv./L)] OSI was calculated by TOS/ TAS rate in percentage [(TOS (µmol H2O2 equivalents/L) / (TAS(µmol Trolox equivalent/L)]. changes of biochemical findings from the beginning to 4th week
See also
  Status Clinical Trial Phase
Completed NCT03995979 - Inflammation and Protein Restriction N/A
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT03577223 - Egg Effects on the Immunomodulatory Properties of HDL N/A
Completed NCT04383561 - Relationship Between LRG and Periodontal Disease N/A
Active, not recruiting NCT03622632 - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT04856748 - Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
Completed NCT05529693 - Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population N/A
Recruiting NCT05670301 - Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases N/A
Recruiting NCT05415397 - Treating Immuno-metabolic Depression With Anti-inflammatory Drugs Phase 3
Recruiting NCT05775731 - Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
Recruiting NCT04543877 - WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study Early Phase 1
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03429920 - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors N/A
Completed NCT06065241 - Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals. N/A
Completed NCT05864352 - The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
Completed NCT03318731 - Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males N/A
Not yet recruiting NCT06134076 - Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota N/A
Not yet recruiting NCT06159543 - The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes N/A