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Full-mouth Treatment Approaches in Severe Chronic Periodontitis.

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ClinicalTrials.gov Identifier: NCT04038801
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Beral Afacan, Aydin Adnan Menderes University

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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Procedure: Quadrant-wise scaling and root planning (Q-SRP) Procedure: Full-mouth ultrasonic debridement (FMUD) Procedure: Full-mouth disinfection (FMD) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical, Microbiological and Biochemical Effectiveness of Full-mouth Treatment Approaches in Severe Chronic Periodontitis: a Randomized Controlled Trial.
Actual Study Start Date : October 1, 2006
Actual Primary Completion Date : May 30, 2008
Actual Study Completion Date : May 30, 2008

Arm Intervention/treatment
Active Comparator: Quadrant-wise scaling and root planning (Q-SRP)
Quadrant-wise scaling and root planing were performed over four visits at 1-weekly intervals using an assortment of manual periodontal curettes.
Procedure: Quadrant-wise scaling and root planning (Q-SRP)
Quadrant-wise scaling and root planing were performed by assortment of manuel periodontal curettes over four visits at 1-weekly intervals.

Experimental: Full-mouth ultrasonic debridement (FMUD)
Subgingival debridement were performed by a piezoceramic ultrasonic inserts in two visits of the same day.
Procedure: Full-mouth ultrasonic debridement (FMUD)
Subgingival debridement were performed by a piezoceramic ultrasonic inserts in two visits of the same day.

Experimental: Full-mouth disinfection (FMD)
Subgingival debridement were performed by a piezoceramic ultrasonic inserts and an intensive regime of chlorhexidine in two visits of the same day.
Procedure: Full-mouth disinfection (FMD)
Subgingival debridement were performed by a piezoceramic ultrasonic inserts and an intensive regime of chlorhexidine in two visits of the same day.




Primary Outcome Measures :
  1. GCF calprotectin [ Time Frame: Change from baseline to 1, 3 and 6 months after treatment. ]
    Calprotectin (pg) levels in GCF.

  2. GCF osteocalcin [ Time Frame: Change from baseline to 1,3 and 6 months after treatment. ]
    Osteocalcin (ng) levels in GCF.

  3. GCF NTx [ Time Frame: Change from baseline to 1,3 and 6 months after treatment. ]
    NTx (nM BCE) levels in GCF.



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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. aged ≥35 years
  2. non-smokers
  3. having at least 15 natural teeth.

Exclusion Criteria:

  1. having any diagnosed medical disorder.
  2. taken antibiotics, non-steroidal anti-inflammatory drugs, immunosuppressants, beta-blockers, calcium channel blockers within the past 6 months.
  3. patients with a history of sensitivity to chlorhexidine.
  4. nonsurgical/surgical periodontal treatment received in the past year
  5. having a restorative and endodontic therapy requirement
  6. having a removable partial denture and/or orthodontic appliances
  7. current pregnancy or lactation.
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Responsible Party: Beral Afacan, Principal Investigator, Aydin Adnan Menderes University
ClinicalTrials.gov Identifier: NCT04038801    
Other Study ID Numbers: FMD
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases