Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305546
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2023-12-05
Brief Title:
Comparisons Of Different Antiplaque Agents On Gingivitis In Orthodontic Patients
Sponsor:
Anam Sattar
Organization:
Dow University of Health Sciences
Study Overview
Official Title:
Comparison Of Different Antiplaque Agents On Gingivitis In Patients Undergoing Fixed Orthodontic Treatment A Double-Blind Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fixed orthodontic treatment affects the periodontium by allowing plaque accumulation on teeth if the oral ecosystem is unfavorable which initially causes gingivitis to progress into periodontitis and later enamel demineralization occurs Yáñez-Vico et al observed that regular modifications per checkups were painful and unpleasant for the patient thus the patients undergoing fixed orthodontic treatments compromised their oral hygiene This creates plaque retention sites which can lead to developing white spot lesions caries and periodontitis
Detailed Description:
Metal brackets were used on the teeth such as incisors canines and premolars as well as bands on the 1st molars to treat all patients with the same kind of orthodontic appliances Metal Brackets were bonded by the principal investigator with the direct bonding technique by using light cure adhesives General oral hygiene instructions were given by the clinician to each participant in the study
Participants were divided into four groups through computer-generated software Group A participants used 1 metronidazole gel Group B participants used 025 chlorhexidine gel Group C participants used a combination gel 1 Metronidazole and 025 Chlorhexidine Group D participants used a placebo gel All participants were instructed to follow oral hygiene measures such as brushing twice a day with a soft brush with fluoridated toothpaste and use of floss or interdental brushes For two weeks all individuals from groups A B C and D were instructed to use pea-sized gel on their gingiva two times a day To ensure patient compliance the investigators assigned patients with log sheets to fill daily on whether they used the gel consistently every day twice a day for 2 weeks Patients were also instructed to return the container of gel on the day of follow-up
OUTCOMES
The primary outcome included the measurement of indices during study time from baseline T0 to 2weeks T1 4 weeks T2 8 weeks T3 and 12 weeksT4 The investigators have evaluated Gingival Index and Bleeding Index by probing and assessing the gingiva and Orthodontic Plaque index by plaque disclosing tablets and examined six standard sites on incisors canine and premolars as described by Gettinger et al Banded first molars were not included because banding itself can compromise periodontal health The study sites were assessed by using CPITN probe Six proximal line angles were investigated for gingivitis on the selected teeth Right maxillary second premolar mesiobuccal line angle right maxillary canine distobuccal line angle left maxillary central incisor distopalatal line angle right mandibular central incisor distolingual line angle left mandibular canine distobuccal line angle left mandibular second premolar mesiobuccal line angle
If any of the study teeth were missing then the corresponding tooth on the opposite side was evaluated
Patients were only included in the trial if they have Gingival index Orthodontic plaque index scores 2 and Bleeding index 1 on any three or more than three of the six teeth that were examined in the study The total combined GI and BI indexes were computed by averaging the measured values at T0 T1 T2 T3 and T4 For OPI the score was calculated by counting the number of teeth with plaque accumulation at each time interval
Participants were divided into four groups through computer-generated software Group A participants used 1 metronidazole gel Group B participants used 025 chlorhexidine gel Group C participants used a combination gel 1 Metronidazole and 025 Chlorhexidine Group D participants used a placebo gel All participants were instructed to follow oral hygiene measures such as brushing twice a day with a soft brush with fluoridated toothpaste and use of floss or interdental brushes For two weeks all individuals from groups A B C and D were instructed to use pea-sized gel on their gingiva two times a day To ensure patient compliance the investigators assigned patients with log sheets to fill daily on whether they used the gel consistently every day twice a day for 2 weeks Patients were also instructed to return the container of gel on the day of follow-up
OUTCOMES
The primary outcome included the measurement of indices during study time from baseline T0 to 2weeks T1 4 weeks T2 8 weeks T3 and 12 weeksT4 The investigators have evaluated Gingival Index and Bleeding Index by probing and assessing the gingiva and Orthodontic Plaque index by plaque disclosing tablets and examined six standard sites on incisors canine and premolars as described by Gettinger et al Banded first molars were not included because banding itself can compromise periodontal health The study sites were assessed by using CPITN probe Six proximal line angles were investigated for gingivitis on the selected teeth Right maxillary second premolar mesiobuccal line angle right maxillary canine distobuccal line angle left maxillary central incisor distopalatal line angle right mandibular central incisor distolingual line angle left mandibular canine distobuccal line angle left mandibular second premolar mesiobuccal line angle
If any of the study teeth were missing then the corresponding tooth on the opposite side was evaluated
Patients were only included in the trial if they have Gingival index Orthodontic plaque index scores 2 and Bleeding index 1 on any three or more than three of the six teeth that were examined in the study The total combined GI and BI indexes were computed by averaging the measured values at T0 T1 T2 T3 and T4 For OPI the score was calculated by counting the number of teeth with plaque accumulation at each time interval
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None