Efficacy of Green and White Tea Extract Mouthwashes in the Management of Plaque-induced Gingivitis: A Clinical and Biochemical Study

NCT05861206 | Completed

• 1 other identifier: RecepTayyipErdoganU.1
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingivitis; Chronic; Oxidative Stress; Inflammation

Keywords

Green tea; White tea; Inflammation; Gingivitis; Oxidative stress

Outcome Measures

Primary Outcomes (10)

• 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

• 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. 1. = 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. 2. = 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. 3. = 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

• 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

• 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, 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.

  changes of clinical findings from the beginning to 4th week

• 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, 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.

  changes of clinical findings from the beginning to 4th week

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

GT-MW group (5% Green tea), WT-MW group (5% White tea), EO-MW group (Listerine mouthrinse)

ACTIVE COMPARATOR

Chronic gingivitis patients whose mechanical plaque control was supported with 5% Green tea. 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 4 weeks. Chronic gingivitis patients whose mechanical plaque control was supported with 5% White tea. 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 4 weeks. Chronic gingivitis patients whose mechanical plaque control was supported with Listerine mouthrinse. 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 4 weeks.

Other: GT-MW group (5% Green tea), WT-MW group (5% White tea),EO-MW group (Listerine mouthrinse)

CHX-MW group (0.12% CHX, as a positive control group)

ACTIVE COMPARATOR

Chronic gingivitis patients whose mechanical plaque control was supported with 0.12% CHX. 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 4 weeks.

Other: CHX-MW group (0.12% CHX, as a positive control group)

Interventions

GT-MW group (5% Green tea), WT-MW group (5% White tea),EO-MW group (Listerine mouthrinse) OTHER

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.

GT-MW group (5% Green tea), WT-MW group (5% White tea), EO-MW group (Listerine mouthrinse)

CHX-MW group (0.12% CHX, as a positive control group) OTHER

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.

CHX-MW group (0.12% CHX, as a positive control group)

Eligibility Criteria

• Age: 18 Years - 32 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yağmur Saraç Gül: lead
• Recep Tayyip Erdogan University: collaborator

Study Sites (1)

Yagmur Sarac Gul

Rize, 53020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingivitis; Bronchiolitis Obliterans Syndrome; Inflammation

Interventions

Tea

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: one of principal investigator

Model Details: 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 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; and usage of any mouthwash in last 6 months.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).

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: May 16, 2023
• Study Start: September 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: December 23, 2022
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: In a six month after the publication
• Access Criteria: Study protocol, statistical analysis plan and clinical study repot will be shared.

Locations

TU (1)