Full-mouth Treatment Approaches in Severe Chronic Periodontitis.
Clinical, Microbiological and Biochemical Effectiveness of Full-mouth Treatment Approaches in Severe Chronic Periodontitis: a Randomized Controlled Trial.
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2006
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2008
CompletedFirst Submitted
Initial submission to the registry
July 27, 2019
CompletedFirst Posted
Study publicly available on registry
July 31, 2019
CompletedJanuary 14, 2020
January 1, 2020
1.7 years
July 27, 2019
January 12, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
GCF calprotectin
Calprotectin (pg) levels in GCF.
Change from baseline to 1, 3 and 6 months after treatment.
GCF osteocalcin
Osteocalcin (ng) levels in GCF.
Change from baseline to 1,3 and 6 months after treatment.
GCF NTx
NTx (nM BCE) levels in GCF.
Change from baseline to 1,3 and 6 months after treatment.
Study Arms (3)
Quadrant-wise scaling and root planning (Q-SRP)
ACTIVE COMPARATORQuadrant-wise scaling and root planing were performed over four visits at 1-weekly intervals using an assortment of manual periodontal curettes.
Full-mouth ultrasonic debridement (FMUD)
EXPERIMENTALSubgingival debridement were performed by a piezoceramic ultrasonic inserts in two visits of the same day.
Full-mouth disinfection (FMD)
EXPERIMENTALSubgingival debridement were performed by a piezoceramic ultrasonic inserts and an intensive regime of chlorhexidine in two visits of the same day.
Interventions
Quadrant-wise scaling and root planing were performed by assortment of manuel periodontal curettes over four visits at 1-weekly intervals.
Subgingival debridement were performed by a piezoceramic ultrasonic inserts in two visits of the same day.
Subgingival debridement were performed by a piezoceramic ultrasonic inserts and an intensive regime of chlorhexidine in two visits of the same day.
Eligibility Criteria
You may qualify if:
- aged ≥35 years
- non-smokers
- having at least 15 natural teeth.
You may not qualify if:
- having any diagnosed medical disorder.
- taken antibiotics, non-steroidal anti-inflammatory drugs, immunosuppressants, beta-blockers, calcium channel blockers within the past 6 months.
- patients with a history of sensitivity to chlorhexidine.
- nonsurgical/surgical periodontal treatment received in the past year
- having a restorative and endodontic therapy requirement
- having a removable partial denture and/or orthodontic appliances
- current pregnancy or lactation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Afacan B, Cinarcik S, Gurkan A, Ozdemir G, Ilhan HA, Vural C, Kose T, Emingil G. Full-mouth disinfection effects on gingival fluid calprotectin, osteocalcin, and N-telopeptide of Type I collagen in severe periodontitis. J Periodontol. 2020 May;91(5):638-650. doi: 10.1002/JPER.19-0445. Epub 2020 Mar 14.
PMID: 32023661DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 27, 2019
First Posted
July 31, 2019
Study Start
October 1, 2006
Primary Completion
May 30, 2008
Study Completion
May 30, 2008
Last Updated
January 14, 2020
Record last verified: 2020-01