Periodontal DiseasesNCT05060601
Minimally Non Surgical Periodontal Therapy Compared to Traditional Approach
A study testing Gracey micro-curettes and Standard Gracey curettes in people with Periodontal Diseases and Periodontal Inflammation, run by Federico II University.
Trial summary
This study aims to evaluate the clinical results of non-surgical periodontal therapy performed with micro-instruments compared to traditional approach (standard curettes) after 6 months of follow-up. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Periodontal Inflammation
- What is being tested?
- Gracey micro-curettes and Standard Gracey curettes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Oct 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Untreated patients diagnosed with severe/advanced periodontitis with slow/moderate rate of progression
- Age > 18 years
- Patients at least 10 teeth per arch
- Presence at least of two teeth with PD > 5 mm per quadrant
- Single-rooted teeth or multi-rooted without furcation involvement
Who cannot join
- Patients with systemic diseases
- Pregnant or lactating
- Tobacco smokers (<10 cigarettes/day)
- Previous periodontal treatment in the last 2 years
- Prolonged antibiotic treatment or anti-inflammatory treatment within 6 months prior to periodontal therapy
- Furcation involvement
- Acute periodontal or endodontic abscesses
- Third molars
About this study
Official title: Healing of Periodontal Pockets Following Treatment With Minimally Non Surgical Approach or Conventional Non Surgical Therapy. A Randomized Controlled Clinical Trial
This study aims to evaluate the clinical results of non-surgical periodontal therapy performed with micro-instruments compared to traditional approach (standard curettes) after 6 months of follow-up.
The patients enrolled, subject to written informed consent, will be divided into a Test group (T) and a Control group (C) through a randomization process. Both groups will be motivated on the rules of oral hygiene, treated scrupulously and monitored monthly for 6 months, at the end of which the final data will be collected for statistical processing (in particular by analyzing the difference between baseline and after 6 months of the parameter "probing depth" or PD).
Read the detailed description
The aim of the study is to evaluate the clinical results of non-surgical periodontal therapy performed with micro-instruments (micro-curettes) compared to traditional instruments (standard curettes) after 6 months of follow-up.
The proposed clinical trial will be conducted according to the principles of the Declaration of Helsinki on experimentation involving human subjects.
All subjects will be recruited from the Area of Odontostomatology - Department of Neuroscience, Reproductive and Odontostomatological Sciences of the University of Naples "Federico II".
In a first phase, all patients will be treated with a supragingival scaling session in order to remove plaque and tartar and it will be provided instructions for a correct oral hygiene. After 1 week, the clinical parameters (PD, FMPS, FMBS, CAL, REC) will be recorded and the subjects randomly assigned to the Test (T) or Control (C) group.
In the Test group, after local anesthesia, subgingival mechanical debridement will be performed using an ultrasonic scaler with specific thin tips and Gracey micro-curette to minimize soft tissue trauma.
In the Control group, after local anesthesia, debridement will be performed using an ultrasonic scaler with specific thin tips and standard Gracey curettes.
At the end of the periodontal therapy, a polishing paste will be applied supragingival in both groups using a rubber cup. An antiseptic therapy based on mouthwash with chlorhexidine digluconate 0.12% (two rinses a day for the first two weeks) will then be recommended. No antibiotics will be prescribed.
Patients from both groups will be called up every month for a professional supragingival cleaning and professional motivation. The final evaluation will be carried out 6 months after the subgingival treatment.
Data analysis will be performed using statistical software (NCSS-PASS, NCSS, Kaysville, UT). The patient will be considered as a statistical unit; however an additional analysis based on the specific dental site will also be performed.
- Conditions
- Periodontal Diseases, Periodontal Inflammation
- Being tested
- Gracey micro-curettes, Standard Gracey curettes
- Keywords
- Periodontitis, Osseous defects, Periodontal therapy
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gracey micro-curettesProcedure or surgery
Mechanical debridement will be performed by means of ultrasonic scalers with specific thin tips and micro-curettes, in order to minimize trauma for gingival tissues.
Standard Gracey curettesProcedure or surgery
After local anaesthesia, non surgical subgingival debridement will be performed by standard Gracey curettes
| Study group | Role | What they receive |
|---|---|---|
| Gracey micro-curettes | Experimental | Subgingival mechanical debridement will be performed using an ultrasonic scaler with specific thin tips and Gracey micro-curette. Receives: Procedure: Gracey micro-curettes |
| Standard Gracey curettes | Active comparator | Subgingival mechanical debridement will be performed using a conventional ultrasonic scaler and standard Gracey curettes. Receives: Procedure: Standard Gracey curettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Probing Depth (PD) (millimeters)
The distance from gingival margin to the bottom of the pocket
Measured: baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy
Secondary outcomes (4)
Change of Full-Mouth Plaque Score (FMPS) (percentage)
Percentage of tooth sites revealing the presence of plaque
Measured: baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy
Change of Full-Mouth Bleeding Score (FMBS) (percentage)
Percentage of tooth sites revealing the presence of bleeding on probing
Measured: baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy
Change of Clinical Attachment Level (CAL) (millimeters)
Distance from the cement-enamel junction to the bottom of the pocket and gingival recession
Measured: baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy
Change of Gingival Recession (GR) (millimeters)
Distance from gingival margin to the cement-enamel junction
Measured: baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start1 Mar 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Federico II 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Ramaglia, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060601
- Sponsor's protocol ID
- 465/20
- Status last verified
- Feb 2024
- First submitted
- 6 Sep 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing of Periodontal Pockets Following Treatment With Minimally Non Surgical Approach or Conventional Non Surgical Therapy. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05060601
- Acronym / sponsor ID
- 465/20
- Conditions
- Periodontal Diseases, Periodontal Inflammation
- Keywords
- Periodontitis, Osseous defects, Periodontal therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 29 Sep 2021 (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.
This study aims to evaluate the clinical results of non-surgical periodontal therapy performed with micro-instruments compared to traditional approach (standard curettes) after 6 months of follow-up.
The patients enrolled, subject to written informed consent, will be divided into a Test group (T) and a Control group (C) through a randomization process. Both groups will be motivated on the rules of oral hygiene, treated scrupulously and monitored monthly for 6 months, at the end of which the final data will be collected for statistical processing (in particular by analyzing the difference between baseline and after 6 months of the parameter "probing depth" or PD).
Detailed description
The aim of the study is to evaluate the clinical results of non-surgical periodontal therapy performed with micro-instruments (micro-curettes) compared to traditional instruments (standard curettes) after 6 months of follow-up.
The proposed clinical trial will be conducted according to the principles of the Declaration of Helsinki on experimentation involving human subjects.
All subjects will be recruited from the Area of Odontostomatology - Department of Neuroscience, Reproductive and Odontostomatological Sciences of the University of Naples "Federico II".
In a first phase, all patients will be treated with a supragingival scaling session in order to remove plaque and tartar and it will be provided instructions for a correct oral hygiene. After 1 week, the clinical parameters (PD, FMPS, FMBS, CAL, REC) will be recorded and the subjects randomly assigned to the Test (T) or Control (C) group.
In the Test group, after local anesthesia, subgingival mechanical debridement will be performed using an ultrasonic scaler with specific thin tips and Gracey micro-curette to minimize soft tissue trauma.
In the Control group, after local anesthesia, debridement will be performed using an ultrasonic scaler with specific thin tips and standard Gracey curettes.
At the end of the periodontal therapy, a polishing paste will be applied supragingival in both groups using a rubber cup. An antiseptic therapy based on mouthwash with chlorhexidine digluconate 0.12% (two rinses a day for the first two weeks) will then be recommended. No antibiotics will be prescribed.
Patients from both groups will be called up every month for a professional supragingival cleaning and professional motivation. The final evaluation will be carried out 6 months after the subgingival treatment.
Data analysis will be performed using statistical software (NCSS-PASS, NCSS, Kaysville, UT). The patient will be considered as a statistical unit; however an additional analysis based on the specific dental site will also be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gracey micro-curettes | Experimental | Procedure: Gracey micro-curettesSubgingival mechanical debridement will be performed using an ultrasonic scaler with specific thin tips and Gracey micro-curette. |
| Standard Gracey curettes | Active comparator | Procedure: Standard Gracey curettesSubgingival mechanical debridement will be performed using a conventional ultrasonic scaler and standard Gracey curettes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Untreated patients diagnosed with severe/advanced periodontitis with slow/moderate rate of progression
- Age > 18 years
- Patients at least 10 teeth per arch
- Presence at least of two teeth with PD > 5 mm per quadrant
- Single-rooted teeth or multi-rooted without furcation involvement
Key exclusion criteria (8 listed)
- Patients with systemic diseases
- Pregnant or lactating
- Tobacco smokers (<10 cigarettes/day)
- Previous periodontal treatment in the last 2 years
- Prolonged antibiotic treatment or anti-inflammatory treatment within 6 months prior to periodontal therapy
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 |
|---|---|---|
| Gracey micro-curettesMechanical debridement will be performed by means of ultrasonic scalers with specific thin tips and micro-curettes, in order to minimize trauma for gingival tissues. | Procedure or surgery | Gracey micro-curettes |
| Standard Gracey curettesAfter local anaesthesia, non surgical subgingival debridement will be performed by standard Gracey curettes | Procedure or surgery | Standard Gracey curettes |
Primary outcome
Change of Probing Depth (PD) (millimeters)
Time frame: baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy
The distance from gingival margin to the bottom of the pocket
4 secondary outcomes
Change of Full-Mouth Plaque Score (FMPS) (percentage)
Time frame: baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy
Change of Full-Mouth Bleeding Score (FMBS) (percentage)
Time frame: baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy
Change of Clinical Attachment Level (CAL) (millimeters)
Time frame: baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy
Change of Gingival Recession (GR) (millimeters)
Time frame: baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Gracey micro-curettes and Standard Gracey curettes in people with Periodontal Diseases and Periodontal Inflammation, run by Federico II University.
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 5 inclusion and 8 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 28 Feb 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?
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?
Change of Probing Depth (PD) (millimeters) (time frame: baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy). 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 28 Feb 2024.