Polynucleotides and Hyaluronic Acid vs Enamel Matrix Proteins in the Treatment of Intrabony Defects (PN-HAVSEMPIND)
Polynucleotides and Hyaluronic Acid vs Enamel Matrix Derivative Proteins in the Treatment of Intrabony Defects: A Randomized Controlled Clinical Trial
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
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Shashi Dadlani, Dentistry
- Telefonní číslo: +34629462321
- E-mail: dadlanishashi@gmail.com
Studijní záloha kontaktů
- Jméno: Gustavo Cabello Dominguez, Dentistry
- Telefonní číslo: +34625693980
- E-mail: info@clinicanexus.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Regenerative periodontal surgery using Regenfast® (hyaluronic acid + polynucleotides) with Bio-Oss®
Name: Regenfast® + Bio-Oss® Intervention: Hyaluronic acid + polynucleotides (Regenfast®) combined with bovine bone graft (Bio-Oss®) Procedure: Applied during minimally invasive periodontal regenerative surgery
|
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 |
|
Aktivní komparátor: Regenerative periodontal surgery using Emdogain® (enamel matrix derivative) with Bio-Oss®
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: 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 |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Clinical Attachment Level
Časové okno: Baseline, 12 months, 3 years, and 5 years after surgery
|
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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Probing Pocket Depth
Časové okno: Baseline, 12 months, 3 years, and 5 years post-surgery
|
Probing Pocket Depth (PPD) will be measured as the distance from the gingival margin to the base of the periodontal pocket using a calibrated periodontal probe (PCP-UNC 15).
Measurements will be taken at six sites per tooth.
Changes in PPD from baseline to follow-up visits will be used to assess periodontal healing and reduction of periodontal pocket depth.
|
Baseline, 12 months, 3 years, and 5 years post-surgery
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Flemmig TF. Periodontitis. Ann Periodontol. 1999 Dec;4(1):32-8. doi: 10.1902/annals.1999.4.1.32.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Resorpce kostí
- Nemoci kostí
- Nemoci pohybového aparátu
- Parodontální atrofie
- Parodontální onemocnění
- Nemoci úst
- Stomatognátní onemocnění
- Ztráta alveolární kosti
- Paradentóza
- Nukleové kyseliny, nukleotidy a nukleosidy
- Uhlohydráty
- Glykosaminoglykany
- Polysacharidy
- Nukleotidy
- Kyselina hyaluronová
- Polynucleotides
Další identifikační čísla studie
- 26042703
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Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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