Periodontal Bone LossNCT05315804
Treatment of Intraosseous Periodontal Defects With Amelogenins
A study testing MINSD and amelogenins and MINSD in people with Periodontal Bone Loss and Periodontal Pocket, run by Federico II University at 1 site in Italy.
Trial summary
The aim of the present investigation will be evaluate the healing of periodontal intraosseous defects following Minimally Invasive Non Surgical Debridement (MINSD) and application of amelogenins, compared to MINSD alone. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Bone Loss, Periodontal Pocket
- What is being tested?
- MINSD and amelogenins and MINSD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2023to 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
- Patients diagnosed with periodontitis;
- Age ≥ 18 years old;
- Presence of at least 10 teeth per arch;
- Presence of at least two teeth with Probing Depth (PD) ≥ 5 mm per quadrant;
- Presence of at least one intraosseous pocket;
- Single-rooted and multi-rooted teeth.
Who cannot join
- Patients with systemic diseases;
- Prolonged antibiotic or anti-inflammatory treatment within 4 weeks prior to periodontal therapy;
- Pregnant or lactating;
- Tobacco smokers (≥ 10 cigarettes per day);
- Multi-rooted teeth with furcation involvement;
- Third molars.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Naples Federico II
Naples, 80131
Luca Ramaglia, +393476912911, luca.ramaglia@unina.it
About this study
Official title: Treatment of Intraosseous Periodontal Pockets by Non-surgical Therapy With Micro-instruments and Application of Amelogenins. A Randomized-controlled Clinical Trial
The aim of the present investigation will be evaluate the healing of periodontal intraosseous defects following Minimally Invasive Non Surgical Debridement (MINSD) and application of amelogenins, compared to MINSD alone.
A total of 22 patients will be enrolled, selected by inclusion and exclusion criteria and randomly divided in two groups: amelogenin (A) and no-amelogenin group (B).
Read the detailed description
The objective of the study will be compare the healing of periodontal intraosseous defects following treatment with Minimally Invasive Non Surgical Debridement (MINSD) and application of amelogenins compared to MINSD alone.
Twenty-two patients with intraosseous periodontal defects will be randomly assigned to treatment with MINSD and application of amelogenins (A Group) or MINSD alone (B Group).
Primary outcome will be "Clinical Attachment Level" (CAL) gain, while the secondary outcomes will be "Probing Depth" (PD), "Gingival Recession" (GR) and "Radiographic Defect Angle" (RDA).
After local anesthesia, in A group MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, amelogenins in gel will be applied in the intraosseous periodontal pockets using a sterile syringe with plasticized needle.
In the B group, only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.
Finally, a polishing paste will be applied to the supra-gingival level in both groups using a rubber cup. Patients of both groups will be recalled every month for professional oral hygiene and, after 6 months, all measurements will be repeated and the final evaluation will be carried out.
- Conditions
- Periodontal Bone Loss, Periodontal Pocket
- Being tested
- MINSD and amelogenins, MINSD
- Keywords
- Amelogenin, Periodontal Therapy, Periodontal Bone Loss, Intraosseous Bone Defect
- Medical subject headings
- Alveolar Bone Loss, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINSD and amelogeninsOther
After local anesthesia, MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, amelogenins in gel will be applied to the intraosseous periodontal pockets using a sterile syringe with plasticized needle.
MINSDOther
Only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.
| Study group | Role | What they receive |
|---|---|---|
| Amelogenin Group (A) | Experimental | Amelogenins in gel will be applied in intraosseous periodontal defects, after Minimally Invasive Non Surgical Debridement (MINSD) Receives: Other: MINSD and amelogenins |
| No-amelogenin Group (B) | Active comparator | Only Minimally Invasive Non Surgical Debridement (MINSD) will be performed Receives: Other: MINSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Clinical Attachment Level (CAL) gain (millimeters)
Distance from the cementoenamel junction to the bottom of the pocket
Measured: baseline and 6 months after periodontal therapy
Secondary outcomes (3)
Change of Probing Depth (PD) (millimeters)
Distance from the gingival margin to the bottom of the pocket
Measured: baseline and 6 months after periodontal therapy
Change of Gingival Recession (GR) (millimeters)
Distance from gingival margin to the cementoenamel junction
Measured: baseline and 6 months after periodontal therapy
Change of Radiographic Defect Angle (RDA) (grade °)
Radiographic intraosseous angle
Measured: baseline and 6 months after periodontal therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Feb 2023
- Primary completion1 Jul 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 Bone LossStudies 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
- Model description
- The study will be designed as a double-arm randomized controlled clinical trial. The intraosseous defects of subjects allocated in A group will be treated with MINSD and application of amelogenins in gel, while in B Group only MINSD will be performed. The null hypothesis of no statistically significant differences between the two modalities for the treatment of intraosseous defects will be tested.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 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
- Investigators
- Luca Ramaglia, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315804
- Sponsor's protocol ID
- 477/21
- Status last verified
- Feb 2024
- First submitted
- 30 Mar 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- Treatment of Intraosseous Periodontal Pockets by Non-surgical Therapy With Micro-instruments and Application of Amelogenins. A Randomized-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05315804
- Acronym / sponsor ID
- 477/21
- Conditions
- Periodontal Bone Loss, Periodontal Pocket
- Keywords
- Amelogenin, Periodontal Therapy, Periodontal Bone Loss, Intraosseous Bone Defect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 7 Apr 2022 (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 present investigation will be evaluate the healing of periodontal intraosseous defects following Minimally Invasive Non Surgical Debridement (MINSD) and application of amelogenins, compared to MINSD alone.
A total of 22 patients will be enrolled, selected by inclusion and exclusion criteria and randomly divided in two groups: amelogenin (A) and no-amelogenin group (B).
Detailed description
The objective of the study will be compare the healing of periodontal intraosseous defects following treatment with Minimally Invasive Non Surgical Debridement (MINSD) and application of amelogenins compared to MINSD alone.
Twenty-two patients with intraosseous periodontal defects will be randomly assigned to treatment with MINSD and application of amelogenins (A Group) or MINSD alone (B Group).
Primary outcome will be "Clinical Attachment Level" (CAL) gain, while the secondary outcomes will be "Probing Depth" (PD), "Gingival Recession" (GR) and "Radiographic Defect Angle" (RDA).
After local anesthesia, in A group MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, amelogenins in gel will be applied in the intraosseous periodontal pockets using a sterile syringe with plasticized needle.
In the B group, only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.
Finally, a polishing paste will be applied to the supra-gingival level in both groups using a rubber cup. Patients of both groups will be recalled every month for professional oral hygiene and, after 6 months, all measurements will be repeated and the final evaluation will be carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study will be designed as a double-arm randomized controlled clinical trial. The intraosseous defects of subjects allocated in A group will be treated with MINSD and application of amelogenins in gel, while in B Group only MINSD will be performed. The null hypothesis of no statistically significant differences between the two modalities for the treatment of intraosseous defects will be tested.
| Arm | Type | Receives |
|---|---|---|
| Amelogenin Group (A) | Experimental | Other: MINSD and amelogeninsAmelogenins in gel will be applied in intraosseous periodontal defects, after Minimally Invasive Non Surgical Debridement (MINSD) |
| No-amelogenin Group (B) | Active comparator | Other: MINSDOnly Minimally Invasive Non Surgical Debridement (MINSD) will be performed |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed with periodontitis;
- Age ≥ 18 years old;
- Presence of at least 10 teeth per arch;
- Presence of at least two teeth with Probing Depth (PD) ≥ 5 mm per quadrant;
- Presence of at least one intraosseous pocket;
Key exclusion criteria (6 listed)
- Patients with systemic diseases;
- Prolonged antibiotic or anti-inflammatory treatment within 4 weeks prior to periodontal therapy;
- Pregnant or lactating;
- Tobacco smokers (≥ 10 cigarettes per day);
- Multi-rooted teeth with furcation involvement;
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 |
|---|---|---|
| MINSD and amelogeninsAfter local anesthesia, MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, amelogenins in gel will be applied to the intraosseous periodontal pockets using a sterile syringe with plasticized needle. | Other | Amelogenin Group (A) |
| MINSDOnly subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette. | Other | No-amelogenin Group (B) |
Primary outcome
Change of Clinical Attachment Level (CAL) gain (millimeters)
Time frame: baseline and 6 months after periodontal therapy
Distance from the cementoenamel junction to the bottom of the pocket
3 secondary outcomes
Change of Probing Depth (PD) (millimeters)
Time frame: baseline and 6 months after periodontal therapy
Change of Gingival Recession (GR) (millimeters)
Time frame: baseline and 6 months after periodontal therapy
Change of Radiographic Defect Angle (RDA) (grade °)
Time frame: baseline and 6 months after 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.
Luca Ramaglia principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MINSD and amelogenins and MINSD in people with Periodontal Bone Loss and Periodontal Pocket, run by Federico II University at 1 site in Italy.
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 6 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 28 Feb 2024. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Ramaglia (+393476912911, luca.ramaglia@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Clinical Attachment Level (CAL) gain (millimeters) (time frame: baseline and 6 months after 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.