PeriodontitisNCT06319261
Efficacy of Guided Biofilm Therapy (GBT) for Treatment of Deep Periodontal Pockets.
A study testing guided biofilm therapy and root surface debridement in people with Periodontitis, run by University of Baghdad.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- guided biofilm therapy and root surface debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read more
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:
- Sites treated with GBT.
- Sites treated with conventional manual instrumentation only.
- Conditions
- Periodontitis
- Being tested
- guided biofilm therapy, root surface debridement
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guided biofilm therapyProcedure or surgery
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 debridementProcedure or surgery
Removing plaque and calculus by conventional root surface debridement
| Study group | Role | What they receive |
|---|---|---|
| guided biofilm therapy group | Active comparator | Sites treated with guided biofilm therapy. Receives: Procedure: guided biofilm therapy |
| conventional root debridement group | Other | Sites treated with conventional manual instrumentation only. Receives: Procedure: root surface debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study startApr 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Hussain Faisal, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319261
- Sponsor's protocol ID
- 858623
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Guided Biofilm Therapy (GBT) for Treatment of Deep Periodontal Pockets: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06319261
- Acronym / sponsor ID
- 858623
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Sites treated with GBT.
- Sites treated with conventional manual instrumentation only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| guided biofilm therapy group | Active comparator | Procedure: guided biofilm therapySites treated with guided biofilm therapy. |
| conventional root debridement group | Other | Procedure: root surface debridementSites treated with conventional manual instrumentation only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| guided biofilm therapyRemoving 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. | Procedure or surgery | guided biofilm therapy group |
| root surface debridementRemoving plaque and calculus by conventional root surface debridement | Procedure or surgery | conventional root debridement group |
Primary outcome
Periodontal pocket depth (PPD)
Time frame: 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.
4 secondary outcomes
Plaque index
Time frame: 3 months
Bleeding on probing
Time frame: 3 months
Relative attachment level
Time frame: 3 months
Changes in the bacterial load
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing guided biofilm therapy and root surface debridement in people with Periodontitis, run by University of Baghdad.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reem Hussain, B.D.S (07702618155, reem.hussein2205@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal pocket depth (PPD) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.