PeriodontitisNCT06105112
Periodontal Regeneration With Hyaluronic Acid or Enamel Matrix Derivatives
A study testing Hyaluronic acid and Enamel matrix derivatives in people with Periodontitis, run by University of Turin, Italy at 1 site in Italy.
Trial summary
To date, the quest for ideal biological inductors for periodontal regeneration is still ongoing, especially when facing non-containing defect anatomies. The primary aim of this study is to evaluate the clinical and radiographic performance of a bone graft combined with either enamel matrix derivatives or hyaluronic… 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?
- Hyaluronic acid and Enamel matrix derivatives
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2023to 1 Sep 2026
- 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
- Diagnosis of stage III-IV periodontitis.
- Completed steps I-II periodontal therapy.
- FMPS <15% at 3-month re-evaluation.
- FMBS <15% at 3-month re-evaluation.
- At least one site with intrabony defects and residual PPD ≥ 6 mm at re-evaluation, with a radiographic intrabony component ≥ 3 mm, and limited to no extension of the defect on the lingual or palatal side as assessed by preoperative bone sounding.
- Intrasurgically, the defect has to present a non-supporting anatomy (1-2 residual walls in its most coronal portion) and it needs to be accessible by flap elevation only on one side (either buccal or oral).
- Signed informed consent.
Who cannot join
- Compromised general health which contraindicates the study procedures (ASA III-VI patients).
- Systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives).
- Current smokers (self-reported, ≥ 10 cigarettes a day), users of chewing tobacco, and drug/alcohol abusers.
- Pregnant or nursing women.
- Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimally Invasive Periodontal Regeneration With a Combination Approach Using Either Hyaluronic Acid or Enamel Matrix Derivatives: a Randomized Controlled Clinical Trial
To date, the quest for ideal biological inductors for periodontal regeneration is still ongoing, especially when facing non-containing defect anatomies. The primary aim of this study is to evaluate the clinical and radiographic performance of a bone graft combined with either enamel matrix derivatives or hyaluronic acid for periodontal regeneration of non-containing intrabony defects in terms of clinical attachment gain (primary outcome) and other secondary outcomes (probing pocket depth reduction, radiographic bone fill). Moreover, this study aims to compare early wound healing and patient-reported outcome measures.
- Conditions
- Periodontitis
- Being tested
- Hyaluronic acid, Enamel matrix derivatives
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acidDevice
Minimally invasive flap elevation and debridement of the intrabony defect with micro-curettes. Root surface debridement with ultrasonic debridement with periotip and mini-curettes. Application of cross-linked hyaluronic acid gel composed of a mixture of cross-linked (1.6%) and natural (0.2%) hyaluronic acid (hyaDent BG, Regedent, Germany) through a syringe over a bone xenograft (Smartgraft, Regedent, Germany). The mixture will be then compacted within the intrabony component of the defect.
Enamel matrix derivativesDevice
Minimally invasive flap elevation and debridement of the intrabony defect with micro-curettes. Root surface debridement with ultrasonic debridement with periotip and mini-curettes. Enamel matrix derivatives gel (Emdogain, Straumann, Switzerland) will be applied on the dry root surfaces and left in place for at least 1 minute avoiding blood contamination. Subsequently, a bone xenograft (Smartgraft, Regedent, Germany) will be compacted within the intrabony component of the defect.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid | Experimental | Minimally invasive surgical technique with a combined approach using hyaluronic acid gel and a bone xenograft. Receives: Device: Hyaluronic acid |
| Enamel matrix derivatives | Active comparator | Minimally invasive surgical technique with a combined approach using enamel matrix derivatives gel and a bone xenograft. Receives: Device: Enamel matrix derivatives |
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 (3)
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
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
Patient reported outcome measures
Pain will be self-recorded by the patient using a visual analog scale (from 0 to 10)
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Oct 2023
- Primary completion1 Oct 2025
- Study completion1 Sep 2026
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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 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
- NCT06105112
- Sponsor's protocol ID
- HATurin
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Periodontal Regeneration With a Combination Approach Using Either Hyaluronic Acid or Enamel Matrix Derivatives: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06105112
- Acronym / sponsor ID
- HATurin
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 27 Oct 2023 (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.
To date, the quest for ideal biological inductors for periodontal regeneration is still ongoing, especially when facing non-containing defect anatomies. The primary aim of this study is to evaluate the clinical and radiographic performance of a bone graft combined with either enamel matrix derivatives or hyaluronic acid for periodontal regeneration of non-containing intrabony defects in terms of clinical attachment gain (primary outcome) and other secondary outcomes (probing pocket depth reduction, radiographic bone fill). Moreover, this study aims to compare early wound healing and patient-reported outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid | Experimental | Device: Hyaluronic acidMinimally invasive surgical technique with a combined approach using hyaluronic acid gel and a bone xenograft. |
| Enamel matrix derivatives | Active comparator | Device: Enamel matrix derivativesMinimally invasive surgical technique with a combined approach using enamel matrix derivatives gel and a bone xenograft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of stage III-IV periodontitis.
- Completed steps I-II periodontal therapy.
- FMPS <15% at 3-month re-evaluation.
- FMBS <15% at 3-month re-evaluation.
- At least one site with intrabony defects and residual PPD ≥ 6 mm at re-evaluation, with a radiographic intrabony component ≥ 3 mm, and limited to no extension of the defect on the lingual or palatal side as assessed by preoperative bone sounding.
Key exclusion criteria (5 listed)
- Compromised general health which contraindicates the study procedures (ASA III-VI patients).
- Systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives).
- Current smokers (self-reported, ≥ 10 cigarettes a day), users of chewing tobacco, and drug/alcohol abusers.
- Pregnant or nursing women.
- Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.
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 |
|---|---|---|
| Hyaluronic acidMinimally invasive flap elevation and debridement of the intrabony defect with micro-curettes. Root surface debridement with ultrasonic debridement with periotip and mini-curettes. Application of cross-linked hyaluronic acid gel composed of a mixture of cross-linked (1.6%) and natural (0.2%) hyaluronic acid (hyaDent BG, Regedent, Germany) through a syringe over a bone xenograft (Smartgraft, Regedent, Germany). The mixture will be then compacted within the intrabony component of the defect. | Device | Hyaluronic acid |
| Enamel matrix derivativesMinimally invasive flap elevation and debridement of the intrabony defect with micro-curettes. Root surface debridement with ultrasonic debridement with periotip and mini-curettes. Enamel matrix derivatives gel (Emdogain, Straumann, Switzerland) will be applied on the dry root surfaces and left in place for at least 1 minute avoiding blood contamination. Subsequently, a bone xenograft (Smartgraft, Regedent, Germany) will be compacted within the intrabony component of the defect. | Device | Enamel matrix derivatives |
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)
3 secondary outcomes
Probing pocket depth change
Time frame: 12 months
Radiographic bone level change
Time frame: 12 months
Patient reported outcome measures
Time frame: 14 weeks
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 23 Oct 2026.
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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 Hyaluronic acid and Enamel matrix derivatives in people with Periodontitis, 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 7 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 23 Oct 2026. 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?
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 23 Oct 2026.