The Response of Pathogens to the Respective or Combined Treatment of SRP and Local Minocycline in Chronic Periodontitis

Chronic Periodontitis Clinical Trial

Official title:

The Response of Periodontal Pathogens to the Respective or Combined Treatment of Scaling and Root Planning and Locally Delivered Minocycline in Patients With Chronic Periodontitis- a Short-term Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02355977
• Other study ID #: 2013-25
• Status: Completed
• Phase: Phase 4
• First received: January 31, 2015
• Last updated: October 29, 2015
• Start date: June 2013
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To evaluate the respective or combinatory efficacy of locally delivered 2% Minocycline (MO) and surface and root planning (SRP) by assessing both clinical parameters and the loads of four main periodontal pathogens in treating chronic periodontitis.

Description:

In this randomized clinical trial, the investigators will evaluate the respective or combinatory efficacy of minocycline and scaling and root planning in the aspects of both clinical parameters [Pocket depth (PD) and sulcus bleeding index (SBI)] and the loads of four main periodontal pathogens [Aggregatibacter actinomycetemcomitans (Aa), Fusobacterium nucleatum (Fn), Porphyromonas gingivalis (Pg) and Prevotella intermedia (Pi)]. Real-time quantitative PCR (qRT-PCR) will be used as a powerful tool with high sensitivity and specificity to quantitatively assess target periodontal bacteria in a period of 7 days. The investigators will also try to correlate the reduction of either total or respective bacteria with the improvements of clinical parameters, with an aim to uncovering the potential microbiological mechanism accounting for the efficacy of a therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• diagnosed with moderate or severe chronic periodontal disease, and exhibited bleeding on probing and attachment loss, with radiographic alveolar bone loss in four or more teeth

Exclusion Criteria:

• pregnant, had used antibiotics within the last 3 months, had periodontal therapy in the past 6 months or had systemic diseases such as heart disease or hypertension

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• minocycline
Periocline dental ointment

Procedure:
• surface and root planning
surface and root planning

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang University	Academic Centre for Dentistry in Amsterdam

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pocket Depth	PD is measured using a standard CPI(community periodontal index) probe (Shanghai Medical Instruments, Shanghai, China) and assessed to the nearest millimeter.	7 days	No
Secondary	Bleeding on Probing	BOP is evaluated for the treated tooth using the sulcus bleeding index (SBI) by Muhlemann with a range of 0 (no bleeding) to 5 (profuse bleeding)	7 days	No
Secondary	Bacterial Load	Real-time quantitative PCR (qRT-PCR) was used as a powerful tool with high sensitivity and specificity to quantitatively assess target periodontal bacteria.	7 days	No