Clarithromycin as Adjuvant to Periodontal Debridement

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ClinicalTrials.gov Identifier: NCT02829983

Recruitment Status : Completed

First Posted : July 12, 2016

Results First Posted : October 17, 2017

Last Update Posted : November 21, 2017

Sponsor:

Collaborator:

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Information provided by (Responsible Party):

Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Condition	Aggressive Periodontitis
Interventions	Drug: Clarithromycin Drug: Placebo Other: One-stage full-mouth ultrasonic debridement (FMUD)
Enrollment	40

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Clarithromycin Group	Placebo Group
Arm/Group Description	20 subjects that received one-stage...	20 subjects that received FMUD asso...
Arm/Group Description	20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days. Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.	20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days). Placebo: Use of placebo tablets twice a day for 3 days. One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.
Period Title: Overall Study
Started	20	20
Completed	20	20
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Clarithromycin Group	Placebo Group	Total
Arm/Group Description		20 subjects that received one-stage...	20 subjects that received FMUD asso...	Total of all reporting groups
Arm/Group Description		20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days. Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.	20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days). Placebo: Use of placebo tablets twice a day for 3 days. One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.	Total of all reporting groups
Overall Number of Baseline Participants		20	20	40
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	20 participants	20 participants	40 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	20 100.0%	20 100.0%	40 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	20 participants	20 participants	40 participants
		31.4 (3.7)	31.25 (4.6)	31.32 (0.10)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	20 participants	20 participants	40 participants
	Female	19 95.0%	19 95.0%	38 95.0%
	Male	1 5.0%	1 5.0%	2 5.0%
Race and Ethnicity Not Collected ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants
				0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants
Brazil	Number Analyzed	20 participants	20 participants	40 participants
Brazil		20 100.0%	20 100.0%	40 100.0%
Probing depht Mean (Standard Deviation) Unit of measure: Milimeter
	Number Analyzed	20 participants	20 participants	40 participants
		3.34 (0.56)	3.53 (0.6)	3.43 (0.13)
clinical attachment level Mean (Standard Deviation) Unit of measure: Milimeter
	Number Analyzed	20 participants	20 participants	40 participants
		3.48 (0.66)	3.63 (0.7)	3.55 (0.1)
bleeding on probing Mean (Standard Deviation) Unit of measure: Percentage of sites
	Number Analyzed	20 participants	20 participants	40 participants
		53 (19)	54 (30)	53.5 (0.7)
gingival recession Mean (Standard Deviation) Unit of measure: Milimeter
	Number Analyzed	20 participants	20 participants	40 participants
		0.14 (0.16)	0.1 (0.12)	0.12 (0.028)
plaque index ^[1] Mean (Standard Deviation) Unit of measure: Percentage of sites
	Number Analyzed	20 participants	20 participants	40 participants
		59 (23)	62 (25)	60.5 (2.12)
		[1] Measure Description: Plaque index is the relation between the sites with deposits of plaque and the sites of full mouth divided for 100.

Outcome Measures

1.Primary Outcome


Title	Clinical Attachment Level
Description	Distance from bottom of pocket to the cement-enamel junction (CEJ).
Description	Distance from bottom of pocket to the cement-enamel junction (CEJ).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Clarithromycin Group	Placebo Group
Arm/Group Description:	20 subjects that received one-stage...	20 subjects that received FMUD asso...
Arm/Group Description:	20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days. Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.	20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days). Placebo: Use of placebo tablets twice a day for 3 days. One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.
Overall Number of Participants Analyzed	20	20
Mean (Standard Deviation) Unit of Measure: milimeter
	2.71 (0.35)	3.03 (0.55)

2.Secondary Outcome


Title	Probing Depth
Description	Distance from the bottom of sulcus/pocket to gingival margin
Description	Distance from the bottom of sulcus/pocket to gingival margin
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Clarithromycin Group	Placebo Group
Arm/Group Description:	20 subjects that received one-stage...	20 subjects that received FMUD asso...
Arm/Group Description:	20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days. Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.	20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days). Placebo: Use of placebo tablets twice a day for 3 days. One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.
Overall Number of Participants Analyzed	20	20
Mean (Standard Deviation) Unit of Measure: milimeter
	2.53 (0.3)	2.86 (0.52)

Adverse Events

Time Frame	1 week after periodontal treatment.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Clarithromycin Group		Placebo Group
Arm/Group Description	20 subjects that received one-stage...		20 subjects that received FMUD asso...
Arm/Group Description	20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days. Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.		20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days). Placebo: Use of placebo tablets twice a day for 3 days. One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.
All-Cause Mortality
	Clarithromycin Group		Placebo Group
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/20 (0.00%)		0/20 (0.00%)
Serious Adverse Events Serious Adverse Events
	Clarithromycin Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0.00%)		0/20 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Clarithromycin Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/20 (10.00%)		0/20 (0.00%)
Gastrointestinal disorders
gastrointestinal discomfort ^†	2/20 (10.00%)	2	0/20 (0.00%)	0
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Mauro Pedrine Santamaria
Organization:	Universidade Estadual Paulista Júlio de Mesquita Filho
Phone:	3947-9033
EMail:	mauro.santamaria@ict.unesp.br

Publications of Results:

Casarin RC, Peloso Ribeiro ED, Sallum EA, Nociti FH Jr, Gonçalves RB, Casati MZ. The combination of amoxicillin and metronidazole improves clinical and microbiologic results of one-stage, full-mouth, ultrasonic debridement in aggressive periodontitis treatment. J Periodontol. 2012 Aug;83(8):988-98. doi: 10.1902/jop.2012.110513. Epub 2012 Jan 30.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Khattri S, Kumbargere Nagraj S, Arora A, Eachempati P, Kusum CK, Bhat KG, Johnson TM, Lodi G. Adjunctive systemic antimicrobials for the non-surgical treatment of periodontitis. Cochrane Database Syst Rev. 2020 Nov 16;11:CD012568. doi: 10.1002/14651858.CD012568.pub2.

Andere NMRB, Castro Dos Santos NC, Araujo CF, Mathias IF, Taiete T, Casarin RCV, Jardini MAN, Shaddox LM, Santamaria MP. Clarithromycin as an Adjunct to One-Stage Full-Mouth Ultrasonic Periodontal Debridement in Generalized Aggressive Periodontitis: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Dec;88(12):1244-1252. doi: 10.1902/jop.2017.170165. Epub 2017 Jul 3.

Layout table for additonal information

Responsible Party:	Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier:	NCT02829983
Other Study ID Numbers:	NMRBA
First Submitted:	July 8, 2016
First Posted:	July 12, 2016
Results First Submitted:	May 9, 2017
Results First Posted:	October 17, 2017
Last Update Posted:	November 21, 2017

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