The aim of this study is to evaluate the efficacy of the test toothpaste compared to a regular fluoride toothpaste in the reducing gingivitis and plaque accumulation in Chinese participants with plaque-induced gingivitis.
This will be a single-center, 12-week, randomized, controlled, examiner-blind, two-group, stratified, parallel group design clinical study in participants with localized plaque-induced gingivitis. The study will investigate the ability of the test toothpaste to improve gingival health and plaque accumulation in participants with plaque induced gingivitis only. Sufficient participants will be screened to randomize approximately 120 participants to ensure approximately 108 participants (approximately 54 per group) complete the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
A toothpaste containing Isopropyl Methyl Phenol (IPMP).
A regular sodium fluoride toothpaste containing 1450 parts per million (ppm).
Shanghai Ninth People's Hospital, Shanghai Jiao Tong Universi-ty School of Medicine
Shanghai, Shanghai Municipality, China
Mean Bleeding Index (Bl) at Week 12
Gingival bleeding will be assessed as an invasive assessment of BI. It will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva with six sites per tooth. To perform the bleeding assessment, a round-ended probe will be inserted approximately 1 millimeter (mm) into the gingival sulcus at approximately 60 degrees and will be moved from the distal interproximal area to the mesial interproximal area. Presence/ absence of gingival bleeding will be assessed for 30 seconds after probing and will be scored on a 3-points scale ranging from 0 to 2, where 0 equal to (=) no bleeding after 30 seconds; 1= bleeding observed within 30 seconds of probing; 2= bleeding observed immediately on probing. Lower score will indicate an improvement in the symptoms.
Time frame: At Week 12
Mean BI At Week 2 and 6
Gingival bleeding will be assessed as an invasive assessment of BI. It will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva with six sites per tooth. To perform the bleeding assessment, a round-ended probe will be inserted approximately 1 mm into the gingival sulcus epithelium at approximately 60 degrees and will be moved from the distal interproximal area to the mesial interproximal area. Presence/ absence of gingival bleeding will be assessed for 30 seconds after probing and will be scored on a 3-points scale ranging from 0 to 2, where 0= no bleeding after 30 seconds; 1= bleeding observed within 30 seconds of probing; 2= bleeding observed an immediately on probing. Lower score will indicate an improvement in the symptoms.
Time frame: At Week 2 and 6
Mean Number of Bleeding Site (NBS) At Week 2, 6 and 12
Gingival bleeding will be assessed as an invasive assessment of BI. It will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva with six sites per tooth. To perform the bleeding assessment, a round-ended probe will be inserted approximately 1 mm into the gingival sulcus epithelium at approximately 60 degrees and will be moved from the distal interproximal area to the mesial interproximal area. The presence/ absence of gingival bleeding will be assessed for 30 seconds after probing. The NBS for each participant will be calculated as the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing.
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Time frame: At Week 2, 6 and 12
Mean Overall Turesky Modification of the Quigley Hein Index (TPI) At Week 2, 6 and 12
TPI will be a non-invasive assessment of supra-gingival plaque accumulation. The plaque will first be disclosed using a plaque disclosing dye solution. The TPI will be assessed for all evaluable surfaces of the facial and lingual surfaces of each scoreable tooth. Three scores will be recorded facially and three lingually, generating six scores per tooth. The disclosed plaques will then be scored using a 6-point scale ranging from 0 to 5, where 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= Thin, continuous band of plaque 1 mm or smaller at the cervical margin of the tooth; 3= Band of plaque wider than 1 mm but covering less than 1/3 of the area; 4= Plaque covering at least 1/3 but less than 2/3 of the area; 5= Plaque covering 2/3 or more of the crown of the tooth. Lower score will indicate an improvement in the symptoms.
Time frame: At Week 2, 6 and 12
Mean Interproximal TPI At Week 2, 6 and 12
TPI will be a non-invasive assessment of supra-gingival plaque accumulation. The plaque will first be disclosed using a plaque disclosing dye solution. The TPI will be assessed for all evaluable surfaces of the facial and lingual surfaces of each scoreable tooth. Three scores will be recorded facially and three lingually, generating six scores per tooth. The disclosed plaques will be scored using a 6-point scale ranging from 0 to 5, where 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= Thin, continuous band of plaque 1 mm or smaller at the cervical margin of the tooth; 3= Band of plaque wider than 1mm but covering less than 1/3 of the area; 4= Plaque covering at least 1/3 but less than 2/3 of the area; 5= Plaque covering 2/3 or more of the crown of the tooth. Lower score will indicate an improvement in the symptoms.
Time frame: At Week 2, 6 and 12
Mean Modified Gingival Index (MGI) At Week 2, 6 and 12
The MGI is a non-invasive visual assessment of gingival health. It will be assessed for all evaluable teeth. For each tooth, scores will be recorded and will be scored on a 5-point scale ranging from 0 to 4, where 0= Absence of inflammation, 1= Mild inflammation; slight or little change in color; little change in texture of any portion of the marginal/ papillary gingival unit, 2= Mild inflammation; criteria as above, but involving the entire marginal/ papillary gingival unit, 3= Moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal/ papillary gingival unit, 4= Severe inflammation; marked redness, edema and/ or hypertrophy of the marginal/ papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Lower score will indicate an improvement in the symptoms.
Time frame: At Week 2, 6 and 12