Trial Outcomes & Findings for Alternative Antibiotic Regime in the Treatment of GAgP (NCT NCT02223702)

Results Overview

We measured the probing depth at baseline, 1st, 3rd and 6th months. The changes were evaluated among and between groups.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

39 participants

Primary outcome timeframe

6-months

Results posted on

2018-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	Amoxicillin+Metronidazole amoxicillin+metronidazole group received a combination of 500 mg of amoxicillin and 500 mg metronidazole three times per day for 7 days. Amoxicillin: 500 mg, 3 times per day for 7 days Metronidazole: 500 mg, 3 times per day, for 7 days	Moxifloxacin The moxifloxacin group received 400 mg moxifloxacin, once in a day for 7 days. Moxifloxacin: 400 mg, once in a day for 7 days.
Overall Study STARTED	20	19
Overall Study COMPLETED	19	15
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alternative Antibiotic Regime in the Treatment of GAgP

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Amoxicillin+Metronidazole n=20 Participants amoxicillin+metronidazole group received a combination of 500 mg of amoxicillin and 500 mg metronidazole three times per day for 7 days. Amoxicillin: 500 mg, 3 times per day for 7 days Metronidazole: 500 mg, 3 times per day, for 7 days	Moxifloxacin n=19 Participants The moxifloxacin group received 400 mg moxifloxacin, once in a day for 7 days. Moxifloxacin: 400 mg, once in a day for 7 days.	Total n=39 Participants Total of all reporting groups
Age, Customized years (older than 18 years, younger than 35 years)	20 participants n=5 Participants	19 participants n=7 Participants	39 participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment Turkey	20 participants n=5 Participants	19 participants n=7 Participants	39 participants n=5 Participants

PRIMARY outcome

Timeframe: 6-months

We measured the probing depth at baseline, 1st, 3rd and 6th months. The changes were evaluated among and between groups.

Outcome measures

Outcome measures
Measure	Amoxicillin+Metronidazole n=19 Participants amoxicillin+metronidazole group received a combination of 500 mg of amoxicillin and 500 mg metronidazole three times per day for 7 days. Amoxicillin: 500 mg, 3 times per day for 7 days Metronidazole: 500 mg, 3 times per day, for 7 days	Moxifloxacin n=15 Participants The moxifloxacin group received 400 mg moxifloxacin, once in a day for 7 days. Moxifloxacin: 400 mg, once in a day for 7 days.
The Primary Outcome Variable Was Probing Depth. Baseline	4.57 mm Standard Deviation 1.08	4.18 mm Standard Deviation 0.62
The Primary Outcome Variable Was Probing Depth. 1st month	3.12 mm Standard Deviation 0.68	2.91 mm Standard Deviation 0.38
The Primary Outcome Variable Was Probing Depth. 3rd month	3.11 mm Standard Deviation 0.6	2.79 mm Standard Deviation 0.33
The Primary Outcome Variable Was Probing Depth. 6th month	3.15 mm Standard Deviation 0.67	3.01 mm Standard Deviation 0.46

SECONDARY outcome

Timeframe: 6-months

Attachment loss were recorded at baseline, 1st, 3rd and 6th months as millimeters. The data were compared among and between groups.

Outcome measures

Outcome measures
Measure	Amoxicillin+Metronidazole n=20 Participants amoxicillin+metronidazole group received a combination of 500 mg of amoxicillin and 500 mg metronidazole three times per day for 7 days. Amoxicillin: 500 mg, 3 times per day for 7 days Metronidazole: 500 mg, 3 times per day, for 7 days	Moxifloxacin n=19 Participants The moxifloxacin group received 400 mg moxifloxacin, once in a day for 7 days. Moxifloxacin: 400 mg, once in a day for 7 days.
The Attachment Loss Were Considered as a Secondary Measure. Baseline	5.03 mm Standard Deviation 1.14	4.94 mm Standard Deviation 0.81
The Attachment Loss Were Considered as a Secondary Measure. 1st month	4.37 mm Standard Deviation 0.87	4.14 mm Standard Deviation 0.87
The Attachment Loss Were Considered as a Secondary Measure. 3rd month	4.41 mm Standard Deviation 0.93	3.98 mm Standard Deviation 0.82
The Attachment Loss Were Considered as a Secondary Measure. 6th month	4.33 mm Standard Deviation 0.94	4.30 mm Standard Deviation 0.93

Adverse Events

Amoxicillin+Metronidazole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Moxifloxacin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chair and Associate Professor of Periodontology

Kocaeli University

Phone: +902623442222

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place