Trial Outcomes & Findings for Efficacy of Amoxicillin-metronidazole Compared to Clindamycin in Patients With Periodontitis and Diabetes (NCT NCT03374176)

Results Overview

The size of the periodontal pocket

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

42 participants

Primary outcome timeframe

7 days

Results posted on

2020-09-16

Participant Flow

The study was carried out on patients at the Integral Dentistry Clinics of the University Center of Health Sciences of the University of Guadalajara in Jalisco, Mexico. The participants attended for dental care from August 2015 to December 2016.

A radiographic examination was undertaken using either periapical films or a pantomogram. Periodontal therapy was initiated within 1month of the baseline screening examination.

Participant milestones

Participant milestones
Measure	AMX-MET AMX-MET Amoxicillin 500 mg + Metronidazole 250 mg. Capsules. 1 capsule tid during 7 days. Amoxicillin 500 mg / Metronidazole 250 mg: Subjects were instructed to take a capsule three times a day for 7 days	Clindamycin Clindamycin Clindamycin 300 mg + placebo. Capsules. 1 capsule tid during 7 days. Clindamycin 300 mg: Subjects were instructed to take a capsule three times a day for 7 days
Overall Study STARTED	21	21
Overall Study COMPLETED	21	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Amoxicillin-metronidazole Compared to Clindamycin in Patients With Periodontitis and Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AMX-MET n=21 Participants 500 mg amoxicillin plus 250 mg metronidazole three times a day for 7days	Clindamycin n=21 Participants 300mg clindamycin plus placebo three times a day for 7days	Total n=42 Participants Total of all reporting groups
Age, Continuous	52.5 years STANDARD_DEVIATION 8.0 • n=5 Participants	52.0 years STANDARD_DEVIATION 10.6 • n=7 Participants	52.2 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Fasting Plasma Glucose	134.1 mg/dL STANDARD_DEVIATION 23.3 • n=5 Participants	136.3 mg/dL STANDARD_DEVIATION 25.7 • n=7 Participants	135.2 mg/dL STANDARD_DEVIATION 24.2 • n=5 Participants
HbA1C	7.1 % STANDARD_DEVIATION 0.4 • n=5 Participants	7.3 % STANDARD_DEVIATION 0.4 • n=7 Participants	7.2 % STANDARD_DEVIATION 0.4 • n=5 Participants
Number of Teeth present in the subjects	25 Teeth STANDARD_DEVIATION 3 • n=5 Participants	24 Teeth STANDARD_DEVIATION 5 • n=7 Participants	24 Teeth STANDARD_DEVIATION 4 • n=5 Participants
Probing depth	2.4 mm STANDARD_DEVIATION 0.6 • n=5 Participants	2.6 mm STANDARD_DEVIATION 0.6 • n=7 Participants	2.5 mm STANDARD_DEVIATION 0.6 • n=5 Participants
Sites with Plaque	40.4 Sites STANDARD_DEVIATION 22.9 • n=5 Participants	40.7 Sites STANDARD_DEVIATION 21.9 • n=7 Participants	40.5 Sites STANDARD_DEVIATION 22.1 • n=5 Participants
Bleeding on Probing	42.4 Sites STANDARD_DEVIATION 24.2 • n=5 Participants	55.6 Sites STANDARD_DEVIATION 25.8 • n=7 Participants	49.0 Sites STANDARD_DEVIATION 25.6 • n=5 Participants

PRIMARY outcome

Timeframe: 7 days

The size of the periodontal pocket

Outcome measures

Outcome measures
Measure	AMX-MET n=21 Participants AMX-MET Amoxicillin 500 mg + Metronidazole 250 mg. Capsules. 1 capsule tid during 7 days. Amoxicillin 500 mg / Metronidazole 250 mg: Subjects were instructed to take a capsule three times a day for 7 days	Clindamycin n=21 Participants Clindamycin Clindamycin 300 mg + placebo. Capsules. 1 capsule tid during 7 days. Clindamycin 300 mg: Subjects were instructed to take a capsule three times a day for 7 days
Probing Depth	0.44 mm Standard Deviation 0.27	0.50 mm Standard Deviation 0.17

SECONDARY outcome

Timeframe: 7 days

0: no plaque 1. separate flecks of plaque at the cervical margin of the tooth 2. a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth 3. a continuous band of plaque wider than 1 mm but covering less than one-third of the crown of the tooth 4. plaque covering at least one-third but less than two-thirds of the crown of the tooth 5. plaque covering two-thirds or more of the crown of the tooth. A higher scores mean a worse outcome

Outcome measures

Outcome measures
Measure	AMX-MET n=21 Participants AMX-MET Amoxicillin 500 mg + Metronidazole 250 mg. Capsules. 1 capsule tid during 7 days. Amoxicillin 500 mg / Metronidazole 250 mg: Subjects were instructed to take a capsule three times a day for 7 days	Clindamycin n=21 Participants Clindamycin Clindamycin 300 mg + placebo. Capsules. 1 capsule tid during 7 days. Clindamycin 300 mg: Subjects were instructed to take a capsule three times a day for 7 days
Sites With Plaques	17.6 Sites Standard Deviation 13.3	15.8 Sites Standard Deviation 10.0

SECONDARY outcome

Timeframe: 7 days

Refers to bleeding on probing 0: absence of inflammation 1. mild inflammation; a slight change in color, little change in the texture of any portion of but not the entire marginal or papillary gingival unit 2. mild inflammation; criteria as above but involving the entire marginal or papillary gingival unit 3. moderate inflammation; glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit 4; severe inflammation; marked redness, edema, and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration

Outcome measures

Outcome measures
Measure	AMX-MET n=21 Participants AMX-MET Amoxicillin 500 mg + Metronidazole 250 mg. Capsules. 1 capsule tid during 7 days. Amoxicillin 500 mg / Metronidazole 250 mg: Subjects were instructed to take a capsule three times a day for 7 days	Clindamycin n=21 Participants Clindamycin Clindamycin 300 mg + placebo. Capsules. 1 capsule tid during 7 days. Clindamycin 300 mg: Subjects were instructed to take a capsule three times a day for 7 days
Sites With Bleeding on Probing	16.1 Sites Standard Deviation 11.2	22.1 Sites Standard Deviation 12.9

SECONDARY outcome

Timeframe: 2 years

The total count of all teeth lost in all participants.

Outcome measures

Outcome measures
Measure	AMX-MET n=21 Participants AMX-MET Amoxicillin 500 mg + Metronidazole 250 mg. Capsules. 1 capsule tid during 7 days. Amoxicillin 500 mg / Metronidazole 250 mg: Subjects were instructed to take a capsule three times a day for 7 days	Clindamycin n=21 Participants Clindamycin Clindamycin 300 mg + placebo. Capsules. 1 capsule tid during 7 days. Clindamycin 300 mg: Subjects were instructed to take a capsule three times a day for 7 days
Total Count of All Teeth Lost Across All Participants	0 total count of all teeth lost	0 total count of all teeth lost

Adverse Events

AMX-MET

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clindamycin

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

Dr. Arieh Roldán Mercado Sesma

Centro Universitario de Tonalá, Universidad de Guadalajara

Phone: +52 (33) 20 00 23 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place