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

NCT06319261 | Not Yet Recruiting DMC

• 1 other identifier: 858623
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Plaque index

  3 months

• Bleeding on probing

  3 months

• Relative attachment level

  3 months

• Changes in the bacterial load

  3 months

Study Arms (2)

guided biofilm therapy group

ACTIVE COMPARATOR

Sites treated with guided biofilm therapy.

Procedure: guided biofilm therapy

conventional root debridement group

OTHER

Sites treated with conventional manual instrumentation only.

Procedure: root surface debridement

Interventions

guided biofilm therapy PROCEDURE

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.

guided biofilm therapy group

root surface debridement PROCEDURE

Removing plaque and calculus by conventional root surface debridement

conventional root debridement group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Smokers.
• 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.

Sponsors & Collaborators

• University of Baghdad: lead

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Reem Hussain, B.D.S

CONTACT

07702618155; reem.hussein2205@codental.uobaghdad.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dentist

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 20, 2024
• Study Start: April 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03