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Efficacy of Guided Biofilm Therapy (GBT) for Treatment of Deep Periodontal Pockets.

Efficacy of Guided Biofilm Therapy (GBT) for Treatment of Deep Periodontal Pockets: A Randomized Clinical Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06319261
Enrollment
25
Registered
2024-03-20
Start date
2024-04-30
Completion date
2024-12-31
Last updated
2024-03-20

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

Conditions

Periodontitis

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: 1. Sites treated with GBT. 2. Sites treated with conventional manual instrumentation only.

Interventions

Removing plaque and calculus by initially detecting it with a disclosing agent followed by the use of air abrasive powder for the removal of supra and subgingival plaque.

Removing plaque and calculus by conventional root surface debridement

Sponsors

University of Baghdad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Adult patients, aged more than 18 years. 2. No history of any systemic diseases. 3. Diagnosed with Stages 3 and 4 periodontitis according to the 2017 World Workshop on the Classification of Periodontal disease. 4. The presence of deep periodontal pocket ≥ 6 mm in two non-adjacent teeth.

Exclusion criteria

1. Smokers. 2. Pregnant and lactating mothers. 3. History of any previous subgingival instrumentation in the last 3 months. 4. The use of antibiotics/non-steroidal anti-inflammatory drugs in the last 3 months. 5. Regular use of medication to control systemic illness. 6. The presence of perio-endo lesion.

Design outcomes

Primary

MeasureTime frameDescription
Periodontal pocket depth (PPD)3 monthsPPD 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

MeasureTime frameDescription
Plaque index3 monthsBiofilm will be determined using a dichotomous scoring system as present (1) or absent (0) after using a disclosing agent to assess the agreement on the scoring of the biofilm.
Bleeding on probing3 monthsBleeding on probing will be recorded as present (1) or absent (0) after probing all the sites by using UNC15 probe.
Relative attachment level3 monthsRelative attachment level will be recorded by making a customized acrylic stent and then measuring the relative attachment level from a fixed point on the stent to the base of the pocket by using UNC15 probe in millimeters.
Changes in the bacterial load3 monthsReal time polymerase chain reaction (qPCR) will be used to assess the detection and the quantity of these periodontal pathogens (P.gingivalis, Aggregatibacter actinomycetemcomitans and filifacter alocis) in the subgingival biofilm sample according to the manufacturer's instructions. identification of target bacteria through PCR will be executed using species specific primers.

Contacts

Primary ContactReem Hussain, B.D.S
reem.hussein2205@codental.uobaghdad.edu.iq07702618155

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026