Evaluation of Efficacy of Full-mouth Disinfection in Generalized Aggressive Periodontitis Patients

Evaluation of Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels and Periodontal Pathogens After Full-Mouth Disinfection Initial Periodontal Treatment in Generalized Aggressive Periodontitis Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02466646

Enrollment

Registered

2015-06-09

Start date

2012-12-31

Completion date

2014-09-30

Last updated

2020-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aggressive Periodontitis

Keywords

Periodontal Debridement, Gingival Crevicular Fluid, Aggressive Periodontitis, Interleukin-1beta, Interleukin-17, Bacteria

Brief summary

The purpose of this study is to determine whether full-mouth disinfection is effective in the initial periodontal treatment of generalized aggressive periodontitis on clinical parameters, gingival crevicular fluid interleukin-1β (IL-1β) and interleukin-17 (IL-17) and periodontal pathogen levels compared with conventional initial periodontal treatment and full-mouth initial periodontal treatment. The investigators' hypothesis is to test whether full-mouth disinfection in the initial periodontal treatment of generalized aggressive periodontitis enhance the clinical, biochemical and microbiological parameters in comparison to conventional initial periodontal treatment and full-mouth initial periodontal treatment.

Detailed description

The present study aimed to compare the efficacy of conventional initial periodontal treatment (C-IPT), full-mouth disinfection IPT (FMD-IPT) and full-mouth IPT (FM-IPT) and the levels of gingival crevicular fluid interleukin-1β (IL-1β) and interleukin-17 (IL-17), Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Fusobacterium nucleatum, Prevotella intermedia, Parvimonas micra and Campylobacter rectus in patients with generalized aggressive periodontitis (GAgP) over 6-months period. Forty-two GAgP patients were randomly assigned into 3 groups. IPT was performed in a quadrant-wise manner at 1-week intervals in C-IPT, in 2 sessions within 24 hours in FM-IPT, and in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours in FMD-IPT. FMD-IPT group also used daily 0,2% chlorhexidine for 3 weeks. At baseline, 3 and 6 months clinical parameters consisting of plaque index, gingival index, probing depth, bleeding on probing and clinical attachment level were recorded, gingival crevicular fluid and microbiological samples were collected. Gingival crevicular fluid levels of IL-1β and IL-17 were analyzed using ELISA. The quantitative real-time polymerase chain reaction method was used for the quantitative detection of periodontal pathogens.

Interventions

DRUGKlorhex® Gel, rinse and spray

Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Spray 0,2% and Klorhex® rinse 0,2% for 3 weeks).

PROCEDUREConventional IPT

Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.

PROCEDUREFull-mouth IPT

Initial periodontal treatment was performed in 2 sessions within 24 hours.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* No systemic diseases that could influence the outcome of the therapy * No smoking * No medications affecting periodontal tissues * No pregnancy or lactation * Presence of at least 15 teeth

Exclusion criteria

* Received antibiotic treatment in the previous 3 months * Smokers * Pregnancy and lactation * Received periodontal treatment in the previous 6 months * Presence of less than 15 teeth * Presence of systemic diseases

Design outcomes

Primary

Measure	Time frame
Probing Depth	6 months after initial periodontal treatment

Secondary

Measure	Time frame	Description
Level of A. Actinomycetemcomitans	Baseline, 3 and 6 months after initial periodontal treatment	—
Level of Porphyromonas Gingivalis	Baseline, 3 and 6 months after initial periodontal treatment	—
Level of Fusobacterium Nucleatum	Baseline, 3 and 6 months after initial periodontal treatment	—
Level of Parvimonas Micra	Baseline, 3 and 6 months after initial periodontal treatment	—
Bleeding on Probing	Baseline, 3 and 6 months after initial periodontal treatment	Possible score for BOP range from %0 (no sites with bleeding on probing) to %100 (all sites with bleeding on probing). Higher scores mean worse outcome.
Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels (pg)	Baseline, 3 and 6 months after initial periodontal treatment	—
Gingival Index	Baseline, 3 and 6 months after initial periodontal treatment	Possible score for Gingival Index range from 0 (healthy gingiva) to 3 (severe gingivitis with bleeding). Higher scores mean worse outcome
Clinical Attachment Level	Baseline, 3 and 6 months after initial periodontal treatment	—
Level of Prevotella Intermedia	Baseline, 3 and 6 months after initial periodontal treatment	—
Level of Campylobacter Rectus	Baseline, 3 and 6 months after initial periodontal treatment	—
Plaque Index	Baseline, 3 and 6 months after initial periodontal treatment	Possible scores for Plaque Index range from 0 (no plaque) to 3 (visible plaque all around the tooth). Higher scores mean a worse outcome

Participant flow

Pre-assignment details

Total of 54 subjects were assessed for eligibility. Prior to assignment of participants, 2 subjects declined to participate and 10 participants were not meeting inclusion criteria

Participants by arm

Arm	Count
Full-mouth Disinfection IPT Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Sprey 0,2% and Klorhex® rinse 0,2% for 3 weeks).	14
Conventional IPT Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.	14
Full-mouth IPT Initial periodontal treatment was performed in 2 sessions within 24 hours.	14
Total	42

Baseline characteristics

Characteristic	Full-mouth Disinfection IPT	Conventional IPT	Full-mouth IPT	Total
Age, Continuous	26.64 years STANDARD_DEVIATION 5.65	29.86 years STANDARD_DEVIATION 6.41	31.86 years STANDARD_DEVIATION 4.56	29.45 years STANDARD_DEVIATION 5.87
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	14 Participants	14 Participants	14 Participants	42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	14 Participants	14 Participants	14 Participants	42 Participants
Sex: Female, Male Female	10 Participants	7 Participants	8 Participants	25 Participants
Sex: Female, Male Male	4 Participants	7 Participants	6 Participants	17 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	0 / 14	0 / 14	0 / 14
serious Total, serious adverse events	0 / 0	0 / 0	0 / 0

Outcome results

Primary

Probing Depth

Time frame: 6 months after initial periodontal treatment

Arm	Measure	Group	Value (MEAN)	Dispersion
Full-mouth Disinfection IPT	Probing Depth	Baseline Probing Depth (PD)	4.55 mm	Standard Deviation 0.72
Full-mouth Disinfection IPT	Probing Depth	6th month PD	2.71 mm	Standard Deviation 0.29
Conventional IPT	Probing Depth	Baseline Probing Depth (PD)	4.80 mm	Standard Deviation 0.62
Conventional IPT	Probing Depth	6th month PD	3.40 mm	Standard Deviation 0.5
Full-mouth IPT	Probing Depth	Baseline Probing Depth (PD)	4.90 mm	Standard Deviation 0.62
Full-mouth IPT	Probing Depth	6th month PD	3.04 mm	Standard Deviation 0.39

p-value: <0.01Kruskal-Wallis

Secondary

Bleeding on Probing

Possible score for BOP range from %0 (no sites with bleeding on probing) to %100 (all sites with bleeding on probing). Higher scores mean worse outcome.