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Completed

NCT Number: NCT01122862

Effect of a Commercial Cosmetic Mouth Rinse on Plaque Re-growth

A clinical study to evaluate the effect of a commercial mouth rinse on plaque re-growth

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Key information

Conditions

Healthy Subjects Dental Deposits Dental Plaque Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site

Fort Wayne, Indiana, 46825, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Good general and oral health
  • At least 20 natural gradable teeth
  • Mean plaque score (Turesky Modification of the Quigley Hein Index) of greater than or equal to 2.00 at the first baseline visit

Treatment and study plan

0.12% chlorhexidine mouthrinse

Drug

commercially available 0.12% chlorhexidine mouthrinse

Cosmetic mouthrinse

Other

Commerically available cosmetic mouthrinse

Sterile Water

Other

Sterile water

Primary outcomes

  1. Plaque Index of Test Mouth Rinse Versus Sterile Water After Day 4 of Treatment Administration

    Time frame: Day 4 post treatment administration

    Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 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 crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.

Secondary outcomes

  1. Plaque Index Score of Test Mouth Rinse Versus Chlorhexidine Mouth Rinse After Day 4 of Treatment Administration

    Time frame: Day 4 post treatment administration

    Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 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 crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.

  2. Plaque Index After 24 Hours of Treatment Administration

    Time frame: Day 1 post treatment administration

    Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 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 crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.

  3. Interproximal Plaque Index After Day 4 of Treatment Administration

    Time frame: Day 4 post treatment administration

    Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 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 crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.

  4. Interproximal Plaque Index After 24 Hours of Treatment Administration

    Time frame: Day 1 post treatment administration

    Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 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 crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Clinical Study to Evaluate the Effect of a Commercial Cosmetic Mouth Rinse on Plaque Re-growth

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 13, 2010
Registry last updated
Sep 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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