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

NCT ID: NCT06319261

Last Updated: 2024-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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guided biofilm therapy group

Sites treated with guided biofilm therapy.

Group Type ACTIVE_COMPARATOR

guided biofilm therapy

Intervention Type 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.

conventional root debridement group

Sites treated with conventional manual instrumentation only.

Group Type OTHER

root surface debridement

Intervention Type PROCEDURE

Removing plaque and calculus by conventional root surface debridement

Interventions

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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.

Intervention Type PROCEDURE

root surface debridement

Removing plaque and calculus by conventional root surface debridement

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Baghdad

OTHER

Sponsor Role lead

Responsible Party

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Reem Hussain Faisal

dentist

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Reem Hussain, B.D.S

Role: CONTACT

07702618155

Other Identifiers

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858623

Identifier Type: -

Identifier Source: org_study_id

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