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

Not Applicable

Not yet recruiting

• Conditions: Periodontitis
• Interventions: Procedure: guided biofilm therapy; Procedure: root surface debridement

• Registration Number: NCT06319261
• Lead Sponsor: University of Baghdad

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-18
• Last Update Submitted: 2024-03-18
• Study First Posted: 2024-03-20
• Last Update Posted: 2024-03-20
• Study Start: 2024-04
• Primary Completion: 2024-10
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
guided biofilm therapy group	guided biofilm therapy	Sites treated with guided biofilm therapy.
conventional root debridement group	root surface debridement	Sites treated with conventional manual instrumentation only.

Primary Outcome Measures

Name	Time	Method
Periodontal pocket depth (PPD)	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 Outcome Measures

Name	Time	Method
Relative attachment level	3 months	Relative 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.
Bleeding on probing	3 months	Bleeding on probing will be recorded as present (1) or absent (0) after probing all the sites by using UNC15 probe.
Changes in the bacterial load	3 months	Real 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.
Plaque index	3 months	Biofilm 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.