Evaluation of Injectable Beta-tricalcium Phosphate Clinically in Treatment of Grade II Furcation Involvement
NCT ID: NCT04443972
Last Updated: 2020-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2018-04-12
2020-02-04
Brief Summary
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Detailed Description
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Group II (Control group): included seven Grade II furcation defects treated with granulated beta tricalcium phosphate bone graft covered by resorbable collagen membrane.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PD VitalOs cement® alone
class II furcation defects that will be treated with PD VitalOs cement® alone
PD VitalOs cement®
PD VitalOs cement®\* is a synthetic bone grafting cement designed for bone void filling and bone regeneration in dental surgery
PD VitalOs cement® plus Bone graft and membrane
PD VitalOs cement® and Hydroxyapatite bone graft and biodegradable collagen membrane in the treatment of class II furcation defects.
PD VitalOs cement®
PD VitalOs cement®\* is a synthetic bone grafting cement designed for bone void filling and bone regeneration in dental surgery
Hydroxyapatite bone graft
a bioceramic bone substitute, providing a scaffold for bone deposition
biodegardable collagen membrane
provide efficacious barriers that were interposed between the flap and root surface.
Interventions
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PD VitalOs cement®
PD VitalOs cement®\* is a synthetic bone grafting cement designed for bone void filling and bone regeneration in dental surgery
Hydroxyapatite bone graft
a bioceramic bone substitute, providing a scaffold for bone deposition
biodegardable collagen membrane
provide efficacious barriers that were interposed between the flap and root surface.
Eligibility Criteria
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Inclusion Criteria
* Patient's age between 30 - 50 years.
* Both sexes.
* The patient should be psychologically accepting the procedures.
* Patients should be systemically free.
Exclusion Criteria
* Patients with para functional habits.
* Smokers.
* Pregnant or lactating women.
* Patients who underwent any periodontal surgeries in the study site during the six months prior to study.
30 Years
50 Years
ALL
Yes
Sponsors
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Alexandria University
OTHER
Hams Hamed Abdelrahman
OTHER
Responsible Party
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Hams Hamed Abdelrahman
Assistant lecturer
Principal Investigators
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Ahmed Hosny Elsayed, BDS
Role: PRINCIPAL_INVESTIGATOR
Alexandria University
shahira Ali El Damaty, PHD
Role: STUDY_DIRECTOR
Alexandria University
Gehan Sherif Kotry, PHD
Role: STUDY_DIRECTOR
Alexandria University
Rania Abd El Aziz Fahmy, PHD
Role: STUDY_DIRECTOR
Alexandria University
Locations
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outpatient clinic of oral medicine department, faculty of dentistry, Alexandria university
Alexandria, , Egypt
Countries
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References
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Cutando A, Galindo P, Gomez-Moreno G, Arana C, Bolanos J, Acuna-Castroviejo D, Wang HL. Relationship between salivary melatonin and severity of periodontal disease. J Periodontol. 2006 Sep;77(9):1533-8. doi: 10.1902/jop.2006.050287.
Bowers GM, Schallhorn RG, McClain PK, Morrison GM, Morgan R, Reynolds MA. Factors influencing the outcome of regenerative therapy in mandibular Class II furcations: Part I. J Periodontol. 2003 Sep;74(9):1255-68. doi: 10.1902/jop.2003.74.9.1255.
Laurell L, Gottlow J, Zybutz M, Persson R. Treatment of intrabony defects by different surgical procedures. A literature review. J Periodontol. 1998 Mar;69(3):303-13. doi: 10.1902/jop.1998.69.3.303.
Nasr HF, Aichelmann-Reidy ME, Yukna RA. Bone and bone substitutes. Periodontol 2000. 1999 Feb;19:74-86. doi: 10.1111/j.1600-0757.1999.tb00148.x.
Caton JG. Overview of clinical trials on periodontal regeneration. Ann Periodontol. 1997 Mar;2(1):215-22. doi: 10.1902/annals.1997.2.1.215.
Mendieta C, Williams RC. Periodontal regeneration with bioresorbable membranes. Curr Opin Periodontol. 1994:157-67.
Gray JL, Hancock EB. Guided tissue regeneration. Nonabsorbable barriers. Dent Clin North Am. 1998 Jul;42(3):523-41.
Baum BJ, Mooney DJ. The impact of tissue engineering on dentistry. J Am Dent Assoc. 2000 Mar;131(3):309-18. doi: 10.14219/jada.archive.2000.0174.
Cury PR, Sallum EA, Nociti FH Jr, Sallum AW, Jeffcoatt MK. Long-term results of guided tissue regeneration therapy in the treatment of class II furcation defects: a randomized clinical trial. J Periodontol. 2003 Jan;74(1):3-9. doi: 10.1902/jop.2003.74.1.3.
Basten CH, Ammons WF Jr, Persson R. Long-term evaluation of root-resected molars: a retrospective study. Int J Periodontics Restorative Dent. 1996 Jun;16(3):206-19.
Hamp SE, Nyman S, Lindhe J. Periodontal treatment of multirooted teeth. Results after 5 years. J Clin Periodontol. 1975 Aug;2(3):126-35. doi: 10.1111/j.1600-051x.1975.tb01734.x.
Hirschfeld L, Wasserman B. A long-term survey of tooth loss in 600 treated periodontal patients. J Periodontol. 1978 May;49(5):225-37. doi: 10.1902/jop.1978.49.5.225.
Kenney EB, Lekovic V, Elbaz JJ, Kovacvic K, Carranza FA Jr, Takei HH. The use of a porous hydroxylapatite implant in periodontal defects. II. Treatment of Class II furcation lesions in lower molars. J Periodontol. 1988 Feb;59(2):67-72. doi: 10.1902/jop.1988.59.2.67.
Eickholz P, Hausmann E. Evidence for healing of Class II and Class III furcations 24 months after guided tissue regeneration therapy: digital subtraction and clinical measurements. J Periodontol. 1999 Dec;70(12):1490-500. doi: 10.1902/jop.1999.70.12.1490.
De Leonardis D, Garg AK, Pedrazzoli V, Pecora GE. Clinical evaluation of the treatment of class II furcation involvements with bioabsorbable barriers alone or associated with demineralized freeze-dried bone allografts. J Periodontol. 1999 Jan;70(1):8-12. doi: 10.1902/jop.1999.70.1.8.
Ohura K, Bohner M, Hardouin P, Lemaitre J, Pasquier G, Flautre B. Resorption of, and bone formation from, new beta-tricalcium phosphate-monocalcium phosphate cements: an in vivo study. J Biomed Mater Res. 1996 Feb;30(2):193-200. doi: 10.1002/(SICI)1097-4636(199602)30:23.0.CO;2-M.
Flautre B, Lemaitre J, Maynou C, Van Landuyt P, Hardouin P. Influence of polymeric additives on the biological properties of brushite cements: an experimental study in rabbit. J Biomed Mater Res A. 2003 Aug 1;66(2):214-23. doi: 10.1002/jbm.a.10539.
Meikle MC, Papaioannou S, Ratledge TJ, Speight PM, Watt-Smith SR, Hill PA, Reynolds JJ. Effect of poly DL-lactide--co-glycolide implants and xenogeneic bone matrix-derived growth factors on calvarial bone repair in the rabbit. Biomaterials. 1994 Jun;15(7):513-21. doi: 10.1016/0142-9612(94)90017-5.
Miyamoto S, Takaoka K, Okada T, Yoshikawa H, Hashimoto J, Suzuki S, Ono K. Polylactic acid-polyethylene glycol block copolymer. A new biodegradable synthetic carrier for bone morphogenetic protein. Clin Orthop Relat Res. 1993 Sep;(294):333-43.
Aichelmann-Reidy ME, Yukna RA. Bone replacement grafts. The bone substitutes. Dent Clin North Am. 1998 Jul;42(3):491-503.
Melcher AH. On the repair potential of periodontal tissues. J Periodontol. 1976 May;47(5):256-60. doi: 10.1902/jop.1976.47.5.256. No abstract available.
Blumenthal NM. A clinical comparison of collagen membranes with e-PTFE membranes in the treatment of human mandibular buccal class II furcation defects. J Periodontol. 1993 Oct;64(10):925-33. doi: 10.1902/jop.1993.64.10.925.
Cortellini P, Prato GP. Guided tissue regeneration with a rubber dam: a five-case report. Int J Periodontics Restorative Dent. 1994 Feb;14(1):8-15.
Armitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. doi: 10.1902/annals.1999.4.1.1.
Garrett S, Martin M, Egelberg J. Treatment of periodontal furcation defects. Coronally positioned flaps versus dura mater membranes in class II defects. J Clin Periodontol. 1990 Mar;17(3):179-85. doi: 10.1111/j.1600-051x.1990.tb01083.x.
O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.
SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
Glavind L, Loe H. Errors in the clinical assessment of periodontal destruction. J Periodontal Res. 1967;2(3):180-4. doi: 10.1111/j.1600-0765.1967.tb01887.x. No abstract available.
Other Identifiers
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Furcation invlvement
Identifier Type: -
Identifier Source: org_study_id
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