Polynucleotides and Hyaluronic Acid vs Enamel Matrix Proteins in the Treatment of Intrabony Defects

NCT07589959 | Not Yet Recruiting DMC

• 1 other identifier: 26042703
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to compare two periodontal regenerative treatments in adults with Stage III or IV periodontitis and infrabony periodontal defects ≥3 mm. The study aims to determine whether hyaluronic acid and polynucleotides (Regenfast®) combined with bovine bone graft material (Bio-Oss®) provides similar or improved periodontal regeneration compared with enamel matrix derivative proteins (Emdogain®) combined with Bio-Oss®. Researchers will evaluate:

• Periodontal healing and bone regeneration
• Changes in probing depth, clinical attachment level, gingival recession, and tooth mobility
• Radiographic bone fill
• Survival of treated teeth after 1, 3, and 5 years Participants will:
• Receive initial periodontal treatment and oral hygiene instruction
• Undergo clinical and radiographic evaluation
• Receive minimally invasive periodontal regenerative surgery under local anesthesia
• Be randomly assigned to receive either Regenfast® + Bio-Oss® or Emdogain® + Bio-Oss®
• Attend follow-up visits with periodontal examinations and radiographs over 5 years

Conditions

Periodontal Defect; Periodontitis Stage IV; Periodontal Bone Loss; Periodontitis Stage III

Keywords

Infrabony Periodontal Defects; Polynucleotides; Hyaluronic Acid; Enamel Matrix Proteins

Outcome Measures

Primary Outcomes (1)

• Clinical Attachment Level

  Measured as the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket using a calibrated periodontal probe (PCP-UNC 15). Measurements will be recorded at six sites per tooth. Changes in CAL from baseline to 12 months, 3 years, and 5 years will be used to assess periodontal regeneration and treatment effectiveness.

  Baseline, 12 months, 3 years, and 5 years after surgery

Secondary Outcomes (1)

• Probing Pocket Depth

  Baseline, 12 months, 3 years, and 5 years post-surgery

Study Arms (2)

Regenerative periodontal surgery using Regenfast® (hyaluronic acid + polynucleotides) with Bio-Oss®

EXPERIMENTAL

Name: Regenfast® + Bio-Oss® Intervention: Hyaluronic acid + polynucleotides (Regenfast®) combined with bovine bone graft (Bio-Oss®) Procedure: Applied during minimally invasive periodontal regenerative surgery

Procedure: Regenerative periodontal surgery using Regenfast® (hyaluronic acid + polynucleotides) with Bio-Oss® graft

Regenerative periodontal surgery using Emdogain® (enamel matrix derivative) with Bio-Oss®

ACTIVE COMPARATOR

Name: Emdogain® + Bio-Oss® Intervention: Enamel matrix derivative proteins (Emdogain®) combined with bovine bone graft (Bio-Oss®) Procedure: Applied during minimally invasive periodontal regenerative surgery

Procedure: Regenerative periodontal surgery using Emdogain® (enamel matrix derivative) with Bio-Oss® graft

Interventions

Regenerative periodontal surgery using Emdogain® (enamel matrix derivative) with Bio-Oss® graft PROCEDURE

Procedure: Papilla Preservation Flap • A conservative access flap will be performed such as simplified papilla preservation flap (SPPF). Use of EDTA 24 %, EMDOGAIN AND BIO-OSS® suturing the flap by tension-free primary closure of the interdental papillae and of the mucoperiosteal using 5-0 suture

Regenerative periodontal surgery using Emdogain® (enamel matrix derivative) with Bio-Oss®

Regenerative periodontal surgery using Regenfast® (hyaluronic acid + polynucleotides) with Bio-Oss® graft PROCEDURE

Combination Product: using PAPILLA Preservation Flap + Combined Formulation of Hyaluronic acid and Polydeoxyribonucleotides (PNHA) REGENFAST+ Bio-Oss • A PNHA gel will be placed on the root surfaces and infra-bony defects, followed by a tension-free primary closure of the interdental papillae and of the mucoperiosteal flaps using 5-0 suture

Regenerative periodontal surgery using Regenfast® (hyaluronic acid + polynucleotides) with Bio-Oss®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older
• Non-smokers or light smokers (fewer than 10 cigarettes per day)
• No diabetes or well-controlled diabetes
• At least one infrabony periodontal defect ≥ 3 mm in depth
• Periodontal pocket depth ≥ 6 mm at baseline (after initial treatment)
• Full-mouth plaque and bleeding scores ≤ 20%, ≤15% at re-evaluation
• Ability and willingness to attend follow-up visits for 1, 3, and 5 years
• Teeth included in the study must be healthy from an endodontic point of view or properly root-treated

You may not qualify if:

• Pregnant or breastfeeding women
• Patients with weakened immune systems or significant systemic diseases
• Heavy smokers (more than 10 cigarettes per day)
• Full-mouth plaque or bleeding scores \>20%, \>15%
• Current alcohol or drug abuse
• Patients who have received periodontal treatment within the last 6 months
• Patients unwilling or unable to attend follow-up visits required for the study

Sponsors & Collaborators

• Shashi Dadlani: lead

Related Publications (13)

• Pilloni A, Rojas MA, Trezza C, Carere M, De Filippis A, Marsala RL, Marini L. Clinical effects of the adjunctive use of polynucleotide and hyaluronic acid-based gel in the subgingival re-instrumentation of residual periodontal pockets: A randomized, split-mouth clinical trial. J Periodontol. 2023 Mar;94(3):354-363. doi: 10.1002/JPER.22-0225. Epub 2022 Nov 23.

  PMID: 36189651 BACKGROUND

• Zhai P, Peng X, Li B, Liu Y, Sun H, Li X. The application of hyaluronic acid in bone regeneration. Int J Biol Macromol. 2020 May 15;151:1224-1239. doi: 10.1016/j.ijbiomac.2019.10.169. Epub 2019 Nov 18.

  PMID: 31751713 BACKGROUND

• Miron RJ, Sculean A, Cochran DL, Froum S, Zucchelli G, Nemcovsky C, Donos N, Lyngstadaas SP, Deschner J, Dard M, Stavropoulos A, Zhang Y, Trombelli L, Kasaj A, Shirakata Y, Cortellini P, Tonetti M, Rasperini G, Jepsen S, Bosshardt DD. Twenty years of enamel matrix derivative: the past, the present and the future. J Clin Periodontol. 2016 Aug;43(8):668-83. doi: 10.1111/jcpe.12546. Epub 2016 May 28.

  PMID: 26987551 BACKGROUND

• Nibali L, Cortellini P. Periodontal Osseous Defects: A Treatment-Oriented Classification to Guide Regenerative Treatment Planning. Int J Periodontics Restorative Dent. 2025 Apr 25;45(3):301-315. doi: 10.11607/prd.7125.

  PMID: 39058949 BACKGROUND

• Sculean A, Windisch P, Keglevich T, Fabi B, Lundgren E, Lyngstadaas PS. Presence of an enamel matrix protein derivative on human teeth following periodontal surgery. Clin Oral Investig. 2002 Sep;6(3):183-7. doi: 10.1007/s00784-002-0171-6. Epub 2002 Aug 13.

  PMID: 12271353 BACKGROUND

• Cortellini P, Tonetti MS. Focus on intrabony defects: guided tissue regeneration. Periodontol 2000. 2000 Feb;22:104-32. doi: 10.1034/j.1600-0757.2000.2220108.x. No abstract available.

  PMID: 11276509 BACKGROUND

• Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.

  PMID: 32383274 BACKGROUND

• Rams TE, Listgarten MA, Slots J. Radiographic alveolar bone morphology and progressive periodontitis. J Periodontol. 2018 Apr;89(4):424-430. doi: 10.1002/JPER.17-0279.

  PMID: 29683496 BACKGROUND

• Cortellini P, Tonetti MS. Clinical concepts for regenerative therapy in intrabony defects. Periodontol 2000. 2015 Jun;68(1):282-307. doi: 10.1111/prd.12048.

  PMID: 25867990 BACKGROUND

• Jepsen K, Sculean A, Jepsen S. Complications and treatment errors related to regenerative periodontal surgery. Periodontol 2000. 2023 Jun;92(1):120-134. doi: 10.1111/prd.12504. Epub 2023 Jul 12.

  PMID: 37435999 BACKGROUND

• Heitz-Mayfield LJ, Trombelli L, Heitz F, Needleman I, Moles D. A systematic review of the effect of surgical debridement vs non-surgical debridement for the treatment of chronic periodontitis. J Clin Periodontol. 2002;29 Suppl 3:92-102; discussion 160-2. doi: 10.1034/j.1600-051x.29.s3.5.x.

  PMID: 12787211 BACKGROUND

• Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721.

  PMID: 29926951 BACKGROUND

• Flemmig TF. Periodontitis. Ann Periodontol. 1999 Dec;4(1):32-8. doi: 10.1902/annals.1999.4.1.32.

  PMID: 10863373 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss; Periodontitis

Interventions

Hyaluronic Acid; Polynucleotides

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Shashi Dadlani, Dentistry

CONTACT

+34629462321; dadlanishashi@gmail.com

Gustavo Cabello Dominguez, Dentistry

CONTACT

+34625693980; info@clinicanexus.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director of Clinica Dadlani

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 22, 2031
• Study Completion (Estimated): July 30, 2031
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share