The aim of this study is to compare subject gingival health after 6 weeks of twice daily use of a non-alcohol or alcohol containing mouthrinse and brushing compared to brushing only.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
324
0.2% w/v Chlorhexidine Digluconate, alcohol containing - UK Marketed Mouthwash
0.2% w/v Chlorhexidine Digluconate, without alcohol - UK Marketed Mouthwash
Intertek 4-Front Research - Widnes
Widnes, Cheshire, United Kingdom
4Front, Ellesmere Port
Cheshire, United Kingdom
Intertek - Manchester Science Park
Manchester, United Kingdom
Gingival Severity Index (GSI) Based on the Gingival Index (GI)
Measure of gingival severity averaged across whole mouth site; each site scored 0, 1, 2, 3 based on GI and, 1. GSI = 0 if GI is 0 or 1 (no bleeding) 2. GSI = 1 if GI is 1 or 2 (bleeding)
Time frame: Change from baseline to 6 weeks
Gingival Index
The GI was assessed on the facial and lingual surfaces at six sites on each tooth (facial and lingual - distal papillae, margin and mesial papillae). These assessments were performed on all evaluable teeth using moderate pressure sweeping a blunt ended probe, which was engaged in approximately 1 millimetre (mm) into the gingival crevice. The scores could range from 0-3 (0=Absence of inflammation; 1=Mild Inflammation-Slight change in color slight change in texture, no bleeding on probing; 2=Moderate Inflammation -glazing, redness edema and hypertrophy, bleeding on probing; 3= Severe inflammation-marked redness and hypertrophy, tendency for spontaneous bleeding)
Time frame: Change from baseline to 6 weeks
Turesky Modification of Quigley & Hein Plaque Index for Overall Plaque Scores
Overall plaque scores were calculated taking the average over all tooth sites for a participant. The scores could range from 0-5 (0=No plaque; 1=Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3=A band of plaque wider than 1 mm but covering less than 1/3 of the area to be graded of the crown of the tooth; 4=Plaque covering at least 1/3 but less than 2/3 of the area to be graded of the crown of the tooth; 5=Plaque covering 2/3 or more of the area to be graded of the crown of the tooth)
Time frame: Change from baseline to 6 weeks
Turesky Modification of Quigley & Hein Plaque Index for Interproximal Plaque Scores
Interproximal plaque scores were analyzed on the mesiofacial, distofacial, mesiolingual and distolingual surfaces, and calculated taking the average over all tooth sites for a participant. The scores could range from 0-5 (0=No plaque; 1=Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3=A band of plaque wider than 1 mm but covering less than 1/3 of the area to be graded of the crown of the tooth; 4=Plaque covering at least 1/3 but less than 2/3 of the area to be graded of the crown of the tooth; 5=Plaque covering 2/3 or more of the area to be graded of the crown of the tooth)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Change from baseline to 6 weeks