Intrabony Periodontal DefectNCT04319770
Effectiveness of Hyaluronic Acid in the Regeneration of Infrabony Defects
A study testing enamel matrix derivative (EMD) and hyaluronic acid (HA) in people with Intrabony Periodontal Defect, run by University of Roma La Sapienza.
Trial summary
The purpose of this randomized controlled clinical trial (RCT) is to determine the efficacy hyaluronic acid (HA) versus enamel matrix derivatives (EMD) in the treatment of infrabony periodontal defects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intrabony Periodontal Defect
- What is being tested?
- enamel matrix derivative (EMD) and hyaluronic acid (HA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 6 Sep 2016to 21 Oct 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient related:
- adults aged 18-65 years with periodontal disease
- sites with infrabony defects and persisting pockets [probing pocket depth (PPD) ≥ 5 mm and bleeding on probing (BOP)] at re-evaluation 6 weeks after non-surgical periodontal therapy
- full-mouth plaque score (FMPS)1 and full-mouth bleeding score (FMBS)2 < 20% before surgery
- at least one radiographically detectable infrabony lesion,3
- good physical health.
Show all 10Show fewer
- Site-specific:
- Interproximal angular defects on single-rooted teeth
- radiographic infrabony component ≥ 3 mm
- PPD ≥ 6 mm and CAL ≥ 7 mm.
Who cannot join
- relevant medical conditions contraindicating surgical interventions
- pregnancy or lactation
- tobacco smoking
- untreated periodontal conditions
- any condition associated with poor compliance or failure to maintain good oral hygiene
- acute infectious lesions in areas intended for surgery
- teeth with grade 2 or higher mobility
- restorations or carious lesions on root surfaces that are associated with the intrabony defect.
About this study
Official title: Effectiveness of Hyaluronic Acid Versus Enamel Matrix Derivatives in the Regeneration of Infrabony Defects. A Randomized Controlled Clinical Trial
The purpose of this randomized controlled clinical trial (RCT) is to determine the efficacy hyaluronic acid (HA) versus enamel matrix derivatives (EMD) in the treatment of infrabony periodontal defects.
Read the detailed description
Intrabony defects associated with periodontal pockets represent a risk factor for periodontitis progression and additional loss of attachment if left untreated.
Over the years, several strategies have been implemented for their surgically reconstruction with the aim of pocket reduction and clinical attachment level gain.
Grafting of intrabony periodontal defects has been used extensively over the years incorporating various materials, including autogenic bone, demineralized allogenic bone, xenogenic and alloplastic materials. Controlled clinical studies have shown a significantly higher gain of clinical attachment and radiographic bone gain in intra-bony periodontal defects treated with open flap debridement combined with EMD when compared with open flap debridement alone.
Hyaluronic acid (HAc) is a naturally occurring linear polysaccharide of the extracellular matrix of connective tissue, synovial fluid, and other tissues. It possesses various physiological and structural functions, which include cellular and extracellular interactions, interactions with growth factors and regulation of the osmotic pressure, and tissue lubrication. All these functions help in maintaining the structural and homeostatic integrity of the tissue.
In the field of dentistry, in vitro and animal studies have demonstrated that hyaluronic acid prevents oxygen free-radical damage to granulation tissue, stimulates the clot formation , induces angiogenesis and does not interfere in the calcification nodule during bone formation.
A randomized controlled trial evaluated the effect of local application of 0.8% Hyaluronan gel in conjunction with periodontal surgery. After initial non-surgical periodontal therapy and re-evaluation, defects were randomly assigned to be treated with modified Widman flap surgery in conjunction with either 0.8% Hyaluronan gel (test) or placebo gel (control) application. Statistically, significant differences were noted for Clinical Attachment Level and gingival recession, (P < 0.05) in favor of the test sites. But non-significant results were found regarding PD, BOP and PI values (P > 0.05).
At the present time no comparative data are available about the use of HA versus EMD in treatment of infrabony defects. Therefore the aim of this study will be evaluated the effectiveness of hyaluronic acid versus enamel matrix derivatives alone in the regeneration of infrabony defects.
- Conditions
- Intrabony Periodontal Defect
- Being tested
- enamel matrix derivative (EMD), hyaluronic acid (HA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enamel matrix derivative (EMD)Device
periodontal regenerative surgery with enamel matrix derivative (EMD) (control)
hyaluronic acid (HA)Device
periodontal regenerative surgery with hyaluronic acid (HA) (test)
| Study group | Role | What they receive |
|---|---|---|
| periodontal regenerative surgery + EMD (control) | Active comparator | periodontal regenerative surgery with enamel matrix derivative Receives: Device: enamel matrix derivative (EMD) |
| periodontal regenerative surgery + HA (test) | Experimental | periodontal regenerative surgery with hyaluronic acid Receives: Device: hyaluronic acid (HA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical attachment level (CAL)
Changes in CAL between initial and final. Measured in mm
Measured: baseline, 12, 28 and 24 months
Secondary outcomes (2)
probing pocket depth (PPD)
Changes in PPD between initial and final. Measured in mm
Measured: baseline, 12, 28 and 24 months
gingival recession (GR)
Changes in GR between initial and final. Measured in mm
Measured: baseline, 12, 28 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start6 Sep 2016
- Primary completion21 Oct 2019
- Study completion21 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Intrabony Periodontal DefectStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Pilloni MD DDS MS, University of Roma La Sapienza
- Investigators
- Andrea Pilloni, MD,DDS,MS, Study director, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319770
- Sponsor's protocol ID
- Ref. 3816 - Prot. 2705/15
- Status last verified
- Jun 2020
- First submitted
- 20 Mar 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cortellini P, Pini Prato G, Tonetti MS. Periodontal regeneration of human infrabony defects. I. Clinical measures. J Periodontol. 1993 Apr;64(4):254-60. doi: 10.1902/jop.1993.64.4.254.
PubMed 8483087Esposito M, Grusovin MG, Papanikolaou N, Coulthard P, Worthington HV. Enamel matrix derivative (Emdogain(R)) for periodontal tissue regeneration in intrabony defects. Cochrane Database Syst Rev. 2009 Oct 7;2009(4):CD003875. doi: 10.1002/14651858.CD003875.pub3.
PubMed 19821315Cortellini P, Prato GP, Tonetti MS. The modified papilla preservation technique. A new surgical approach for interproximal regenerative procedures. J Periodontol. 1995 Apr;66(4):261-6. doi: 10.1902/jop.1995.66.4.261.
PubMed 7782979Cortellini P, Prato GP, Tonetti MS. The simplified papilla preservation flap. A novel surgical approach for the management of soft tissues in regenerative procedures. Int J Periodontics Restorative Dent. 1999 Dec;19(6):589-99.
PubMed 10815597Zhao N, Wang X, Qin L, Guo Z, Li D. Effect of molecular weight and concentration of hyaluronan on cell proliferation and osteogenic differentiation in vitro. Biochem Biophys Res Commun. 2015 Sep 25;465(3):569-74. doi: 10.1016/j.bbrc.2015.08.061. Epub 2015 Aug 15.
PubMed 26284973Vanden Bogaerde L. Treatment of infrabony periodontal defects with esterified hyaluronic acid: clinical report of 19 consecutive lesions. Int J Periodontics Restorative Dent. 2009 Jun;29(3):315-23.
PubMed 19537471Fawzy El-Sayed KM, Dahaba MA, Aboul-Ela S, Darhous MS. Local application of hyaluronan gel in conjunction with periodontal surgery: a randomized controlled trial. Clin Oral Investig. 2012 Aug;16(4):1229-36. doi: 10.1007/s00784-011-0630-z. Epub 2011 Oct 20.
PubMed 22012469
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Hyaluronic Acid Versus Enamel Matrix Derivatives in the Regeneration of Infrabony Defects. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04319770
- Acronym / sponsor ID
- Ref. 3816 - Prot. 2705/15
- Conditions
- Intrabony Periodontal Defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 6 Sep 2016 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 21 Oct 2019 (actual)
- First posted
- 24 Mar 2020 (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 purpose of this randomized controlled clinical trial (RCT) is to determine the efficacy hyaluronic acid (HA) versus enamel matrix derivatives (EMD) in the treatment of infrabony periodontal defects.
Detailed description
Intrabony defects associated with periodontal pockets represent a risk factor for periodontitis progression and additional loss of attachment if left untreated.
Over the years, several strategies have been implemented for their surgically reconstruction with the aim of pocket reduction and clinical attachment level gain.
Grafting of intrabony periodontal defects has been used extensively over the years incorporating various materials, including autogenic bone, demineralized allogenic bone, xenogenic and alloplastic materials. Controlled clinical studies have shown a significantly higher gain of clinical attachment and radiographic bone gain in intra-bony periodontal defects treated with open flap debridement combined with EMD when compared with open flap debridement alone.
Hyaluronic acid (HAc) is a naturally occurring linear polysaccharide of the extracellular matrix of connective tissue, synovial fluid, and other tissues. It possesses various physiological and structural functions, which include cellular and extracellular interactions, interactions with growth factors and regulation of the osmotic pressure, and tissue lubrication. All these functions help in maintaining the structural and homeostatic integrity of the tissue.
In the field of dentistry, in vitro and animal studies have demonstrated that hyaluronic acid prevents oxygen free-radical damage to granulation tissue, stimulates the clot formation , induces angiogenesis and does not interfere in the calcification nodule during bone formation.
A randomized controlled trial evaluated the effect of local application of 0.8% Hyaluronan gel in conjunction with periodontal surgery. After initial non-surgical periodontal therapy and re-evaluation, defects were randomly assigned to be treated with modified Widman flap surgery in conjunction with either 0.8% Hyaluronan gel (test) or placebo gel (control) application. Statistically, significant differences were noted for Clinical Attachment Level and gingival recession, (P < 0.05) in favor of the test sites. But non-significant results were found regarding PD, BOP and PI values (P > 0.05).
At the present time no comparative data are available about the use of HA versus EMD in treatment of infrabony defects. Therefore the aim of this study will be evaluated the effectiveness of hyaluronic acid versus enamel matrix derivatives alone in the regeneration of infrabony defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| periodontal regenerative surgery + EMD (control) | Active comparator | Device: enamel matrix derivative (EMD)periodontal regenerative surgery with enamel matrix derivative |
| periodontal regenerative surgery + HA (test) | Experimental | Device: hyaluronic acid (HA)periodontal regenerative surgery with hyaluronic acid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- adults aged 18-65 years with periodontal disease
- sites with infrabony defects and persisting pockets [probing pocket depth (PPD) ≥ 5 mm and bleeding on probing (BOP)] at re-evaluation 6 weeks after non-surgical periodontal therapy
- full-mouth plaque score (FMPS)1 and full-mouth bleeding score (FMBS)2 < 20% before surgery
- at least one radiographically detectable infrabony lesion,3
- good physical health.
Key exclusion criteria (8 listed)
- relevant medical conditions contraindicating surgical interventions
- pregnancy or lactation
- tobacco smoking
- untreated periodontal conditions
- any condition associated with poor compliance or failure to maintain good oral hygiene
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 |
|---|---|---|
| enamel matrix derivative (EMD)periodontal regenerative surgery with enamel matrix derivative (EMD) (control) | Device | periodontal regenerative surgery + EMD (control) |
| hyaluronic acid (HA)periodontal regenerative surgery with hyaluronic acid (HA) (test) | Device | periodontal regenerative surgery + HA (test) |
Primary outcome
clinical attachment level (CAL)
Time frame: baseline, 12, 28 and 24 months
Changes in CAL between initial and final. Measured in mm
2 secondary outcomes
probing pocket depth (PPD)
Time frame: baseline, 12, 28 and 24 months
gingival recession (GR)
Time frame: baseline, 12, 28 and 24 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 4 Jun 2020.
- Results publication: PubMed 8483087Cortellini P, Pini Prato G, Tonetti MS. Periodontal regeneration of human infrabony defects. I. Clinical measures. J Periodontol. 1993 Apr;64(4):254-60. doi: 10.1902/jop.1993.64.4.254.
- Results publication: PubMed 19821315Esposito M, Grusovin MG, Papanikolaou N, Coulthard P, Worthington HV. Enamel matrix derivative (Emdogain(R)) for periodontal tissue regeneration in intrabony defects. Cochrane Database Syst Rev. 2009 Oct 7;2009(4):CD003875. doi: 10.1002/14651858.CD003875.pub3.
- Results publication: PubMed 7782979Cortellini P, Prato GP, Tonetti MS. The modified papilla preservation technique. A new surgical approach for interproximal regenerative procedures. J Periodontol. 1995 Apr;66(4):261-6. doi: 10.1902/jop.1995.66.4.261.
- Results publication: PubMed 10815597Cortellini P, Prato GP, Tonetti MS. The simplified papilla preservation flap. A novel surgical approach for the management of soft tissues in regenerative procedures. Int J Periodontics Restorative Dent. 1999 Dec;19(6):589-99.
- Results publication: PubMed 26284973Zhao N, Wang X, Qin L, Guo Z, Li D. Effect of molecular weight and concentration of hyaluronan on cell proliferation and osteogenic differentiation in vitro. Biochem Biophys Res Commun. 2015 Sep 25;465(3):569-74. doi: 10.1016/j.bbrc.2015.08.061. Epub 2015 Aug 15.
- Results publication: PubMed 19537471Vanden Bogaerde L. Treatment of infrabony periodontal defects with esterified hyaluronic acid: clinical report of 19 consecutive lesions. Int J Periodontics Restorative Dent. 2009 Jun;29(3):315-23.
- Results publication: PubMed 22012469Fawzy El-Sayed KM, Dahaba MA, Aboul-Ela S, Darhous MS. Local application of hyaluronan gel in conjunction with periodontal surgery: a randomized controlled trial. Clin Oral Investig. 2012 Aug;16(4):1229-36. doi: 10.1007/s00784-011-0630-z. Epub 2011 Oct 20.
- 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.
Andrea Pilloni, MD,DDS,MS study director
University of Roma La Sapienza
Questions about this trial
What is this clinical trial studying?
A study testing enamel matrix derivative (EMD) and hyaluronic acid (HA) in people with Intrabony Periodontal Defect, run by University of Roma La Sapienza.
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 10 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: finished, as of the sponsor's last update on 4 Jun 2020. 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?
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 (CAL) (time frame: baseline, 12, 28 and 24 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 NCT04319770, which also lists 7 linked publications.
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 4 Jun 2020.