Gingivitis; ChronicNCT05861206
Efficacy of Green and White Tea Extract Mouthwashes in the Management of Plaque-induced Gingivitis: A Clinical and Biochemical Study
A study testing GT-MW group (5% Green tea), WT-MW group (5% White tea),EO-MW group (Listerine mouthrinse) in people with Gingivitis; Chronic and Oxidative Stress, run by Yağmur Saraç Gül at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis; Chronic, Oxidative Stress, Inflammation
- What is being tested?
- GT-MW group (5% Green tea), WT-MW group (5% White tea),EO-MW group (Listerine mouthrinse)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 23 Dec 2022
- 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 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Gingivitis; Chronic, Oxidative Stress, Inflammation
- Being tested
- 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)
- Keywords
- Green tea, White tea, Inflammation, Gingivitis, Oxidative stress
- Medical subject headings
- Gingivitis, Bronchiolitis Obliterans Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: CHX-MW group (0.12% CHX, as a positive control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
- = 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.
Measured: 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.
Measured: 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,
- = 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.
Measured: 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,
- = 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)].
Measured: changes of biochemical findings from the beginning to 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 Sep 2020
- Primary completion1 Jul 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingivitis; ChronicStudies 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
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yağmur Saraç Gül
- Sponsor type
- University, hospital or other
- Collaborators
- Recep Tayyip Erdogan University
- Responsible party
- Sponsor-investigator, Yağmur Saraç Gül, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861206
- Sponsor's protocol ID
- RecepTayyipErdoganU.1
- Status last verified
- May 2023
- First submitted
- 26 Mar 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publishing of this clinical trial, IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Green and White Tea Extract Mouthwashes in the Management of Plaque-induced Gingivitis: A Clinical and Biochemical Study
- ClinicalTrials.gov ID
- NCT05861206
- Acronym / sponsor ID
- RecepTayyipErdoganU.1
- Conditions
- Gingivitis; Chronic, Oxidative Stress, Inflammation
- Keywords
- Green tea, White tea, Inflammation, Gingivitis, Oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Yağmur Saraç GülUniversity, hospital or other
- Collaborators
- Recep Tayyip Erdogan University
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 16 May 2023 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| GT-MW group (5% Green tea), WT-MW group (5% White tea), EO-MW group (Listerine mouthrinse) | Active comparator | Other: GT-MW group (5% Green tea), WT-MW group (5% White tea),EO-MW group (Listerine mouthrinse)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. |
| CHX-MW group (0.12% CHX, as a positive control group) | Active comparator | Other: CHX-MW group (0.12% CHX, as a positive control group)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. |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| 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. | 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)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. | Other | CHX-MW group (0.12% CHX, as a positive control group) |
Primary outcome
Papillary bleeding index
Time frame: changes of clinical findings from the beginning to 4th week
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.
Plaque index
Time frame: changes of clinical findings from the beginning to 4th week
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.
Probing pocket depth
Time frame: changes of clinical findings from the beginning to 4th week
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.
Tooth staining index
Time frame: changes of clinical findings from the beginning to 4th week
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.
The staining index of the tongue
Time frame: changes of clinical findings from the beginning to 4th week
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.
Biochemical results:IL-1beta(ng/mL)
Time frame: changes of biochemical findings from the beginning to 4th week
IL-1beta(ng/mL), levels were determined in gingival crevicular fluid sample using human-specific commercial ELISA kits according to manufacturer instructions.
Biochemical results:MMP-8(ng/mL)
Time frame: changes of biochemical findings from the beginning to 4th week
MMP-8(ng/mL), levels were determined in gingival crevicular fluid sample using human-specific commercial ELISA kits according to manufacturer instructions.
Biochemical results:Total Oxidatif Status(μmol H2O2 Equiv./L)
Time frame: changes of biochemical findings from the beginning to 4th week
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.
Biochemical results:Total Antioxidative Status(μmol Trolox. Equiv./L)
Time frame: changes of biochemical findings from the beginning to 4th week
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.
Biochemical results:Oxidative Stress Index[(μmol H2O2 Equiv./L)/(μmol Trolox. Equiv./L)]
Time frame: changes of biochemical findings from the beginning to 4th week
OSI was calculated by TOS/ TAS rate in percentage [(TOS (μmol H2O2 equivalents/L) / (TAS(μmol Trolox equivalent/L)].
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 16 May 2023.
- Individual participant dataSharing planned: Yes. After publishing of this clinical trial, IPD will be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GT-MW group (5% Green tea), WT-MW group (5% White tea),EO-MW group (Listerine mouthrinse) in people with Gingivitis; Chronic and Oxidative Stress, run by Yağmur Saraç Gül at 1 site in Turkey (Türkiye).
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 4 inclusion and 7 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 16 May 2023. 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 Turkey (Türkiye). 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?
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?
Papillary bleeding index (time frame: changes of clinical findings from the beginning to 4th week). The study lists 10 primary outcomes in all. 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 16 May 2023.