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

Официальное название

Polynucleotides and Hyaluronic Acid vs Enamel Matrix Derivative Proteins in the Treatment of Intrabony Defects: A Randomized Controlled Clinical Trial

Обзор

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

Подробное описание

This clinical study evaluates two regenerative approaches used during minimally invasive periodontal surgery for the treatment of infrabony periodontal defects deeper than 3 mm. The study compares a combination of hyaluronic acid and polynucleotides (Regenfast®) with enamel matrix derivative proteins (Emdogain®), both used together with a bovine bone graft material (Bio-Oss®).

This is a randomized, multicenter clinical study conducted in three specialized periodontal clinics by experienced periodontists. Adults with Stage III or IV periodontitis who continue to have deep periodontal defects after initial periodontal treatment may be eligible to participate.

Participants will first receive standard non-surgical periodontal treatment, including professional cleaning, root planing, oral hygiene instruction, and chlorhexidine mouth rinses. Eight weeks later, a clinical and radiographic reevaluation will be performed. Patients who meet the study criteria will undergo minimally invasive periodontal surgery using papilla preservation techniques.

During surgery, the periodontal defect will be cleaned and treated with one of the two regenerative materials selected randomly through a sealed-envelope allocation process. Patients will receive either Regenfast® with Bio-Oss® or Emdogain® with Bio-Oss®. All participants will receive local anesthesia, postoperative antibiotics, pain medication, and supportive periodontal care.

Researchers will monitor healing and treatment outcomes through clinical examinations and radiographic evaluations performed at 1 year, 3 years, and 5 years after surgery. Measurements will include periodontal pocket depth, gum recession, clinical attachment level, bleeding on probing, tooth mobility, and the amount of bone regeneration seen on radiographs. The study will also evaluate long-term tooth survival and analyze whether factors such as smoking habits or defect shape influence treatment outcomes.

Вмешательства

• Процедура Regenerative periodontal surgery using Regenfast® (hyaluronic acid + polynucleotides) with Bio-Oss® graft
  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
• Процедура Regenerative periodontal surgery using Emdogain® (enamel matrix derivative) with Bio-Oss® graft
  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

Первичные конечные точки

• Clinical Attachment Level [Срок оценки: Baseline, 12 months, 3 years, and 5 years after surgery]

Вторичные конечные точки (1)

• Probing Pocket Depth [Срок оценки: Baseline, 12 months, 3 years, and 5 years post-surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07589959 · 26042703

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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