Treatment of PeriodontitisNCT06835452
Comparison of Current Subgingival Debridement Methods
An observational study of Treatment of Periodontitis and Guided Biofilm Therapy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Our study aimed to compare the effectiveness of current subgingival debridement methods used in the treatment of Stage 1 and Stage 2 periodontitis patients, the aesthetic condition achieved after these treatments, and the pain felt during treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Treatment of Periodontitis, Guided Biofilm Therapy, Subgingival Plaque
- Type of treatment
- Pill or oral medicine
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jul 2024to 7 Feb 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: 90 female patients with stage 1-2 periodontitis
Who may be able to join
- Systemically healthy patient (without known chronic disease)
- Periodontal diagnostic data (Gingival Index, Plaque Index, Periodontal pocket depths, Attachment loss, Radiological data-Bone loss data) are complete
- Treatments diagnosed with stage 1-2 periodontitis and those who have not had periodontal treatment in the last 6 months
Who cannot join
- Having a systemic disease
- Pregnant and lactating women
- smoker
- Those who do not want to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Current Subgingival Debridement Methods: Clinical Trial with 6 Months Follow-up
Our study aimed to compare the effectiveness of current subgingival debridement methods used in the treatment of Stage 1 and Stage 2 periodontitis patients, the aesthetic condition achieved after these treatments, and the pain felt during treatment.
90 female patients who were diagnosed with chronic periodontitis (Stage 1-2) and required supra-subgingival scaling for treatment purposes, and who volunteered to participate in the study, were included in the study. Three treatment groups were determined. 30 people were included in each group. Periodontal examination was performed before and after the treatments in the 1st month, 3rd month and 6th month and the data on the collected periodontal parameters were analyzed.
Read the detailed description
Periodontal parametreler Gingival index, plaque index, periodontal pocket depth and bleeding index on probing.
It was evaluated with the visual analog scale for pain and aesthetics.
- Conditions
- Treatment of Periodontitis, Guided Biofilm Therapy, Subgingival Plaque, Subgingival Debridement
- Keywords
- guided biofilm therapy, periodontitis, subgingival debridement
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1- classic treatment | Subgingival debridement was performed using the Cavitron and Gracey curette (this is the method that is used routinely). | |
| Group 2-Guided Biofilm Therapy | Subgingival debridement was performed with the Guided Biofilm Therapy (GBT+Airabrasion) method. This method is the most up-to-date method. The biofilm is shown to the patient with plate dye, and the biofilm is cleaned with air abrasion and perio flow (EMS device cavitron). In the patient's control sessions, the patient's oral hygiene motivation is tried to be increased by dyeing the biofilm. | |
| Group 3- Classical treatment and with Plaque paint | the dental calculus and biofilm were stained with plaque paint, shown to the patient with the help of a mirror, and then routine subgingival debridement was performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival index
4 surfaces of all teeth (distal, buccal, mesial, lingual) are evaluated 0= Normal gingiva
- Mild inflammation - slight discoloration, slight edema. There is no bleeding after probing.
- Moderate inflammation - redness, edema and shine. Bleeding after probing.
- Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding.
Measured: baseline, 1st month, 3rd month and 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start24 Jul 2024
- Primary completion1 Feb 2025
- Study completion7 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of PeriodontitisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Nigde Omer Halisdemir University
- Responsible party
- Principal investigator, Selcen Ozcan Bulut, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835452
- Sponsor's protocol ID
- 2023/65
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Current Subgingival Debridement Methods: Clinical Trial with 6 Months Follow-up
- ClinicalTrials.gov ID
- NCT06835452
- Acronym / sponsor ID
- 2023/65
- Conditions
- Treatment of Periodontitis, Guided Biofilm Therapy, Subgingival Plaque, Subgingival Debridement
- Keywords
- guided biofilm therapy, periodontitis, subgingival debridement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Nigde Omer Halisdemir University
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 19 Feb 2025 (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.
Our study aimed to compare the effectiveness of current subgingival debridement methods used in the treatment of Stage 1 and Stage 2 periodontitis patients, the aesthetic condition achieved after these treatments, and the pain felt during treatment.
90 female patients who were diagnosed with chronic periodontitis (Stage 1-2) and required supra-subgingival scaling for treatment purposes, and who volunteered to participate in the study, were included in the study. Three treatment groups were determined. 30 people were included in each group. Periodontal examination was performed before and after the treatments in the 1st month, 3rd month and 6th month and the data on the collected periodontal parameters were analyzed.
Detailed description
Periodontal parametreler Gingival index, plaque index, periodontal pocket depth and bleeding index on probing.
It was evaluated with the visual analog scale for pain and aesthetics.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1- classic treatment | – | –Subgingival debridement was performed using the Cavitron and Gracey curette (this is the method that is used routinely). |
| Group 2-Guided Biofilm Therapy | – | –Subgingival debridement was performed with the Guided Biofilm Therapy (GBT+Airabrasion) method. This method is the most up-to-date method. The biofilm is shown to the patient with plate dye, and the biofilm is cleaned with air abrasion and perio flow (EMS device cavitron). In the patient's control sessions, the patient's oral hygiene motivation is tried to be increased by dyeing the biofilm. |
| Group 3- Classical treatment and with Plaque paint | – | –the dental calculus and biofilm were stained with plaque paint, shown to the patient with the help of a mirror, and then routine subgingival debridement was performed. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 90 female patients with stage 1-2 periodontitis
Key inclusion criteria (3 listed)
- Systemically healthy patient (without known chronic disease)
- Periodontal diagnostic data (Gingival Index, Plaque Index, Periodontal pocket depths, Attachment loss, Radiological data-Bone loss data) are complete
- Treatments diagnosed with stage 1-2 periodontitis and those who have not had periodontal treatment in the last 6 months
Key exclusion criteria (4 listed)
- Having a systemic disease
- Pregnant and lactating women
- smoker
- Those who do not want to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gingival index
Time frame: baseline, 1st month, 3rd month and 6th month
4 surfaces of all teeth (distal, buccal, mesial, lingual) are evaluated 0= Normal gingiva 1. Mild inflammation - slight discoloration, slight edema. There is no bleeding after probing. 2. Moderate inflammation - redness, edema and shine. Bleeding after probing. 3. Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Treatment of Periodontitis
Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Cohort Study on the Non-Surgical Treatment of Periapical Inflammatory Lesions With Vitapex Paste
Periapical Periodontitis, Periapical Abscess
Not yet recruiting
Spirulina Gel in the Treatment of Periodontitis
Periodontitis, Periodontitis Stage II
Not yet recruitingEarly Phase 1
The Efficacy of Exosomes Combined With Synthetic Bone Graft for the Treatment of Periodontal Intra-bony Defects
Intra-Bony Defects in Periodontitis Patients
Recruiting
Effect of Different Apical Motion Algorithms on Postoperative Pain After Root Canal Treatment
Apical Periodontitis, Postoperative Pain After Endodontic Treatment
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment of Periodontitis and Guided Biofilm Therapy, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival index (time frame: baseline, 1st month, 3rd month and 6th month). 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 19 Feb 2025.