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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: guided biofilm therapy; Procedure: root surface debridement

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reem Hussain, B.D.S; Phone Number: 07702618155; Email: reem.hussein2205@codental.uobaghdad.edu.iq

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: guided biofilm therapy group; Sites treated with guided biofilm therapy.	Procedure: guided biofilm therapy; 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.
Other: conventional root debridement group; Sites treated with conventional manual instrumentation only.	Procedure: root surface debridement; Removing plaque and calculus by conventional root surface debridement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periodontal pocket depth (PPD)	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.	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Baghdad

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Periodontal Pocket
• Other Study ID Numbers: 858623

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No