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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06319261
• Other study ID #: 858623
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: University of Baghdad
• Contact: Reem Hussain, B.D.S
• Phone: 07702618155
• Email: reem.hussein2205[@]codental.uobaghdad.edu.iq
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Pocket
• Periodontitis

Intervention

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.
• root surface debridement
Removing plaque and calculus by conventional root surface debridement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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