Periodontitis, AdultNCT05456555
The Flapless Approach in Periodontal Regeneration
A study testing Flapless with Enamel Matrix Derivatives (EMD) and Flapless without Enamel Matrix Derivatives (EMD) in people with Periodontitis, Adult and Intrabony Periodontal Defect, run by University of Turin, Italy at 1 site in Italy.
Trial summary
The present investigation is designed in order to compare the radiographic and clinical effectiveness of flapless procedure performed alone or in combination with enamel matrix derivatives in the periodontal regenerative treatment of deep intrabony defects in patients with moderate or severe periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Adult, Intrabony Periodontal Defect
- What is being tested?
- Flapless with Enamel Matrix Derivatives (EMD) and Flapless without Enamel Matrix Derivatives (EMD)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2022to 15 Dec 2023
- 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
- diagnosis of periodontitis stage III or IV;
- presence of at least one tooth with ≥6 mm associated with a radiographic intrabony defect ≥3 mm at least 2 months after the completion of non-surgical therapy;
- a full-mouth plaque score and full-mouth bleeding score <15% at the time of the experimental procedure;
- signed informed consent.
Who cannot join
- relevant medical disorders contraindicating periodontal surgery or detrimental to periodontal healing;
- consumption of drugs known to affect periodontal status;
- pregnancy and lactation;
- third molars, teeth with furcation involvement or inadequate endodontic treatment and/or prosthetic restoration;
- heavy smokers >10 cigarettes per day.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Flapless Approach With and Without Enamel Matrix Derivatives in the Regenerative Treatment of Intrabony Defects: a Randomized Controlled Clinical Trial
The present investigation is designed in order to compare the radiographic and clinical effectiveness of flapless procedure performed alone or in combination with enamel matrix derivatives in the periodontal regenerative treatment of deep intrabony defects in patients with moderate or severe periodontitis. The study will have a follow-up of 12 months.
- Conditions
- Periodontitis, Adult, Intrabony Periodontal Defect
- Being tested
- Flapless with Enamel Matrix Derivatives (EMD), Flapless without Enamel Matrix Derivatives (EMD)
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flapless with Enamel Matrix Derivatives (EMD)Procedure or surgery
Experimental sites will receive a closed non-surgical treatment with a combined use of minicurettes and ultrasonic instruments with thin and delicate tips. Teeth will be instrumented until no residual calculus could be detected. A visualization of the root surface will be accomplished under magnification by using dental loups 4.0X. In the test group, the roots will be conditioned with 24% ethylenediaminetetraacetic acid (EDTA) for 2 minutes. After rinsing with sterile saline, enamel matrix derivatives (EMD) will be applied on the dried root surface.
Flapless without Enamel Matrix Derivatives (EMD)Procedure or surgery
Experimental sites will receive a closed non-surgical treatment with a combined use of minicurettes and ultrasonic instruments with thin and delicate tips. Teeth will be instrumented until no residual calculus could be detected. A visualization of the root surface will be accomplished under magnification by using dental loups 4.0X. No adjunct will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Flapless with Enamel Matrix Derivatives (EMD) | Experimental | Closed non-surgical treatment of periodontal intrabony defects with the combined use of Enamel Matrix Derivatives (EMD). Receives: Procedure: Flapless with Enamel Matrix Derivatives (EMD) |
| Flapless alone | Active comparator | Closed non-surgical treatment of periodontal intrabony defects without any adjunct. Receives: Procedure: Flapless without Enamel Matrix Derivatives (EMD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level change
Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Measured: 12 months
Secondary outcomes (2)
Radiographic bone level change
Periapical standardized radiographs will be taken by a clinician masked to the clinical measurements using the paralleling technique and individually customized bite-blocks (RINN XCP Film Holding Instruments, Dentsply, York, USA)
Measured: 12 months
Probing pocket depth change
Probing depth will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Sep 2022
- Primary completion1 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontitis, AdultStudies of the same condition, open and under way.
- 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Aimetti, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456555
- Sponsor's protocol ID
- EMDTurin1
- Status last verified
- Dec 2023
- First submitted
- 8 Jul 2022
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aimetti M, Stasikelyte M, Mariani GM, Cricenti L, Baima G, Romano F. The flapless approach with and without enamel matrix derivatives for the treatment of intrabony defects: A randomized controlled clinical trial. J Clin Periodontol. 2024 Sep;51(9):1112-1121. doi: 10.1111/jcpe.14028. Epub 2024 Jun 10.
PubMed 38859627
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Flapless Approach With and Without Enamel Matrix Derivatives in the Regenerative Treatment of Intrabony Defects: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05456555
- Acronym / sponsor ID
- EMDTurin1
- Conditions
- Periodontitis, Adult, Intrabony Periodontal Defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 13 Jul 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 present investigation is designed in order to compare the radiographic and clinical effectiveness of flapless procedure performed alone or in combination with enamel matrix derivatives in the periodontal regenerative treatment of deep intrabony defects in patients with moderate or severe periodontitis. The study will have a follow-up of 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flapless with Enamel Matrix Derivatives (EMD) | Experimental | Procedure: Flapless with Enamel Matrix Derivatives (EMD)Closed non-surgical treatment of periodontal intrabony defects with the combined use of Enamel Matrix Derivatives (EMD). |
| Flapless alone | Active comparator | Procedure: Flapless without Enamel Matrix Derivatives (EMD)Closed non-surgical treatment of periodontal intrabony defects without any adjunct. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of periodontitis stage III or IV;
- presence of at least one tooth with ≥6 mm associated with a radiographic intrabony defect ≥3 mm at least 2 months after the completion of non-surgical therapy;
- a full-mouth plaque score and full-mouth bleeding score <15% at the time of the experimental procedure;
- signed informed consent.
Key exclusion criteria (5 listed)
- relevant medical disorders contraindicating periodontal surgery or detrimental to periodontal healing;
- consumption of drugs known to affect periodontal status;
- pregnancy and lactation;
- third molars, teeth with furcation involvement or inadequate endodontic treatment and/or prosthetic restoration;
- heavy smokers >10 cigarettes per day.
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 |
|---|---|---|
| Flapless with Enamel Matrix Derivatives (EMD)Experimental sites will receive a closed non-surgical treatment with a combined use of minicurettes and ultrasonic instruments with thin and delicate tips. Teeth will be instrumented until no residual calculus could be detected. A visualization of the root surface will be accomplished under magnification by using dental loups 4.0X. In the test group, the roots will be conditioned with 24% ethylenediaminetetraacetic acid (EDTA) for 2 minutes. After rinsing with sterile saline, enamel matrix derivatives (EMD) will be applied on the dried root surface. | Procedure or surgery | Flapless with Enamel Matrix Derivatives (EMD) |
| Flapless without Enamel Matrix Derivatives (EMD)Experimental sites will receive a closed non-surgical treatment with a combined use of minicurettes and ultrasonic instruments with thin and delicate tips. Teeth will be instrumented until no residual calculus could be detected. A visualization of the root surface will be accomplished under magnification by using dental loups 4.0X. No adjunct will be administered. | Procedure or surgery | Flapless alone |
Primary outcome
Clinical attachment level change
Time frame: 12 months
Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
2 secondary outcomes
Radiographic bone level change
Time frame: 12 months
Probing pocket depth change
Time frame: 12 months
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 Dec 2023.
- Derived from this study: PubMed 38859627Aimetti M, Stasikelyte M, Mariani GM, Cricenti L, Baima G, Romano F. The flapless approach with and without enamel matrix derivatives for the treatment of intrabony defects: A randomized controlled clinical trial. J Clin Periodontol. 2024 Sep;51(9):1112-1121. doi: 10.1111/jcpe.14028. Epub 2024 Jun 10.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flapless with Enamel Matrix Derivatives (EMD) and Flapless without Enamel Matrix Derivatives (EMD) in people with Periodontitis, Adult and Intrabony Periodontal Defect, run by University of Turin, Italy 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 4 inclusion and 5 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 Dec 2023. 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?
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?
Clinical attachment level change (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05456555, which also lists 1 linked publication.
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 Dec 2023.