Efficacy of Guided Biofilm Therapy (GBT) for Treatment of Deep Periodontal Pockets: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Baghdad
- Enrollment
- 25
- Primary Endpoint
- Periodontal pocket depth (PPD)
Study Overview
Brief Summary
the aim of the study is to evaluate the efficacy of guided biofilm therapy (GBT) for treatment of deep periodontal pockets.
the objectives are
1- To compare the change in the clinical periodontal parameters and microbiological parameters by using real time PCR for P. gingivalis, Aggregatibacter actinomycetemcomitans and Filifactor alocis among sites treated by GBT and conventional hand instrumentation after a period of 3 months and to assess the level of the selected periodontal pathogens in deep periodontal pockets and to estimate and compare deep periodontal pockets which need surgery after 3 months of non-surgical treatment by GBT and conventional hand instrumentation.
the hypothesis is whether there are no differences in in the clinical and microbiological parameters among sites treated by GBT and conventional hand instrumentation after a period of 3 months or there are differences in in the clinical and microbiological parameters among sites treated by GBT and conventional hand instrumentation after a period of 3 months.
The participants will be selected on a consecutive basis from patients referred to the Department of Periodontics, College of Dentistry, University of Baghdad.
For each patient, each site will be randomly assigned to either treatment protocol:
- Sites treated with GBT.
- Sites treated with conventional manual instrumentation only.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adult patients, aged more than 18 years.
- •No history of any systemic diseases.
- •Diagnosed with Stages 3 and 4 periodontitis according to the 2017 World Workshop on the Classification of Periodontal disease.
- •The presence of deep periodontal pocket ≥ 6 mm in two non-adjacent teeth.
Exclusion Criteria
- •Pregnant and lactating mothers.
- •History of any previous subgingival instrumentation in the last 3 months.
- •The use of antibiotics/non-steroidal anti-inflammatory drugs in the last 3 months.
- •Regular use of medication to control systemic illness.
- •The presence of perio-endo lesion.
Arms & Interventions
guided biofilm therapy group
Sites treated with guided biofilm therapy.
Intervention: guided biofilm therapy (Procedure)
conventional root debridement group
Sites treated with conventional manual instrumentation only.
Intervention: root surface debridement (Procedure)
Outcomes
Primary Outcomes
Periodontal pocket depth (PPD)
Time Frame: 3 months
PPD will be measured from the gingival margin to the base of the pocket by using the University of North Carolina 15 probe (UNC15) probe to measure the reduction of the pocket depth in millimeters.
Secondary Outcomes
- Relative attachment level(3 months)
- Bleeding on probing(3 months)
- Changes in the bacterial load(3 months)
- Plaque index(3 months)
Investigators
Reem Hussain Faisal
dentist
University of Baghdad