Chronic Periodontitis Clinical Trial
Official title:
Clinical, Microbiological and Biochemical Effectiveness of Full-mouth Treatment Approaches in Severe Chronic Periodontitis: a Randomized Controlled Trial.
This study aimed to compare the effects of full-mouth disinfection (FMD) and full-mouth ultrasonic debridement (FMUD) on clinical, microbiologic and biochemical parameters with conventional quadrant-wise scaling and root planning (Q-SRP) in patients with severe chronic periodontitis. 60 patients with severe chronic periodontitis were randomly allocated to three groups: FMD (n=20), FMUD (n=20) and Q-SRP (n=20). At baseline, gingival crevicular fluid (GCF) and subgingival plaque were collected and clinical periodontal parameters were recorded. Ultrasonic debridement was completed within 24 hours in FMD and FMUD groups. Chlorhexidine gluconate was used for FMD. Q-SRP was performed by hand instruments per quadrant at 1-week-intervals. Clinical parameters were recorded and samples were collected at 1, 3, 6 months after treatment. Real-time PCR was used for quantitative analysis of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia, Fusobacterium nucleatum and total bacteria count. Calprotectin, osteocalcin and cross-linked N-telopeptide of type I collagen (NTx) levels in GCF were analysed by enzyme-linked immunosorbent assay.
Study population and clinical examination
60 consecutive severe chronic periodontitis patients were recruited for the study.
The whole mouth clinical periodontal examination included measurement of probing depth,
clinical attachment level and plaque index at 6 sites per tooth, except the third molars The
papillary bleeding index was recorded for the entire oral cavity. Clinical periodontal
parameters were recorded at baseline and 1 month, 3 months and 6 months after treatments.
Alveolar bone loss were assessed using an digital panoromic radiograph in each participant.
The diagnosis of severe chronic periodontitis was based on clinical and radiographic
diagnostic criteria proposed by 1999 International Workshop for a Classification of
Periodontal Diseases and Conditions. These individuals had a minimum of four non-adjacent
teeth with sites with PD ≥6 mm and CAL ≥5 mm. They had also ≥50% alveolar bone loss in at
least two quadrants that was commensurate with amount of plaque accumulation.
All clinical measurements, GCF and plaque sampling and also all treatments were performed by
the same calibrated and trained investigator (B.A.) in a standardized manner (single-blinded
trial).
Treatment
At the baseline visit, immediately before non-surgical periodontal treatment GCF and
subgingival plaque samples were collected per patient and clinical periodontal measurements
were recorded in all groups.
In the Q-SRP group, SRP were started with the upper right quadrant, and continued clockwise
over four visits at 1-weekly intervals. SRP was performed using an assortment of manual
periodontal curettes. The tooth surfaces were instrumented until it was visually and
tactilely free of all deposits. Re-examinations were performed at 1, 3 and 6 months following
the completion of the SRP in the lower right quadrant.
In the FMUD group, subgingival debridement were performed in upper jaw at the morning session
and in lower jaw at the afternoon session. The procedure was completed in two visits (with 45
minutes interval) of the same day. All periodontal sites were debrided by a piezoceramic
ultrasonic instrument with unmodified and modified inserts. Each tooth was instrumented till
the root surface was visually and tactilely clean and smooth. Re-examinations were performed
at 1, 3 and 6 months after the completion of full-mouth subgingival debridman.
In the FMD group, ultrasonic subgingival debridman was combined with an intensive
antimicrobial regime with chlorhexidine. The dorsum of the tongue was brushed with a 1%
chlorhexidine gel for 1 minute. The patients were instructed to rinse twice for 1 minute with
0.2% chlorhexidine solution. Each tonsil was sprayed four times with 0.2% chlorhexidine
spray. Repeated subgingival irrigation with 1% chlorhexidine gel of all the pockets by a
blunt needle. This subgingival application was repeated at day 8. For 14 days after the
treatment, the patients were instructed to rinse twice daily for 1 min with 0.2%
chlorhexidine solution and to spray the tonsils twice daily with a 0.2% chlorhexidine spray.
Re-examinations were performed at 1, 3 and 6 months after 14 days washout period.
Standard oral hygiene instructions were given all patients immediately after the first
session of Q-SRP group and the completion of the ultrasonic debridement in FMD and FMUD
groups.
GCF sampling
GCF was sampled from the buccal aspects of two nonadjacent interproximal sites in
single-rooted teeth with PD ≥6 mm, CAL ≥5 mm and visible signs of inflammation at baseline.
Re-sampling was repeated at 1 month, 3 months and 6 months after treatment. Standardized
filter paper strips were used for GCF sampling. The absorbed fluid volume was measured with a
precalibrated electronic device. The paper strips were stored at −40◦C for further analysis.
Subgingival plaque sampling
After GCF collection, the subgingival plaque samples were collected from one site per
quadrant with the deepest PD (≥5 mm) of single-rooted teeth at baseline and 1 month, 3 months
and 6 months after treatment using two standardized no.30 sterile paper points. Pooled
samples were stored at −40◦C for further analysis.
Measurement of calprotectin, osteocalcin, and NTx levels in GCF.
Two paper strips were pooled, placed in 300 microliter phosphatebuffered saline containing
0.05% polysorbate 20 and incubated for 20 minutes at room temperature on an orbital shaker.
The fluid from the paper strips was recovered by centrifugation at 13 000 rpm for 5 minutes
at +4◦C. Calprotectin, osteocalcin and NTx levels in GCF samples were measured by ELISA using
commercial kits in line with the manufacturer's guidelines. Plates were measured at 450 nm
with 650 nm as a reference wavelength by using an ELISA reader. Cytokine concentrations were
calculated from the standard curve. GCF results were expressed as total amounts at two sites
per sampling time.
Molecular detection of target bacteria in subgingival plaque.
The quantitative real-time PCR (qPCR) method was used for the quantitative detection of the
selected periodontal pathogens in subgingival plaque. Total microbial DNA on paperpoints were
extracted using High Pure PCR Template Preparation Kit according to the manufacturer's
instructions. LightCycler FastStart DNA Master SYBR Green I Kit was used for the detection of
target oligonucleotides according to the manufacturer's instructions. Real-time PCR protocols
were constructed considering specific primer sets. Standard curves were constructed for the
calculation of target oligonucleotides in the samples.
Statistical Analysis
Repeated measures analysis of variance (ANOVA) was used to detect intra- and intergroup
differences in clinical, microbiological and biochemical parameters. Analysis of covariance
was used for comparison of the improvements in parameters between the three treatment groups
adjusting for the potential difference in the baseline data and Bonferroni test was performed
post-hoc. The significance level was set at p <0.05.
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