Clinical trial NCT04443972: Evaluation of Injectable Beta-tricalcium Phosphate Clinically in Treatment of Grade II Furcation Involvement
Official title: Evaluation of Injectable Beta- Tricalcium Phosphate as an Occlusive Barrier Membrane in Treatment of Grade ii Furcation Involvement (Clinical and Radiographic Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Furcation Defects
Keywords: Grade II Furcation defects
Lead sponsor: Alexandria University
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2020-06-23
Enrollment: 14
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to evaluate clinically and radiographically the use of PD VitalOs cement® bone graft in the treatment of class II furcation defects comparing with Hydroxyapatite bone graft and biodegradable collagen membrane in the treatment of class II furcation defects.

Detailed description: The study is a randomized, controlled clinical trial. Patients were randomly divided into two equal groups, Group I (Test group): included seven Grade II furcation defects treated by beta tricalcium phosphate bone cement only.

Group II (Control group): included seven Grade II furcation defects treated with granulated beta tricalcium phosphate bone graft covered by resorbable collagen membrane.

Eligibility criteria: Inclusion Criteria:

* • Presence of a lower molar with critical size grade II furcation defect (15) with a horizontal component of 4 mm and a vertical component of 4 to 6 mm (18), detected using Naber's probe and William's periodontal probe.

  * Patient's age between 30 - 50 years.
  * Both sexes.
  * The patient should be psychologically accepting the procedures.
  * Patients should be systemically free.

Exclusion Criteria:

* • Uncooperative patients regarding oral hygiene measures performance.

  * 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.

Primary outcomes:
measure: change in plaque index scores (PI) according to Silness and Löe.
timeFrame: at 3 weeks and 6 weeks
measure: change in probing Pocket Depth(PPD)
timeFrame: at 3 weeks and 6 weeks
measure: change in clinical Attachment Level
timeFrame: at 3 weeks and 6 weeks
Secondary outcomes:
measure: change in radiographic bone level (RBL)
timeFrame: at basline, 3 and 6 months
measure: change in optical density(OD)
timeFrame: at basline, 3 and 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: outpatient clinic of oral medicine department, faculty of dentistry, Alexandria university
Study officials:
affiliation: Alexandria University
name: Ahmed Hosny Elsayed, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: shahira Ali El Damaty, PHD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Gehan Sherif Kotry, PHD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Rania Abd El Aziz Fahmy, PHD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Mendieta C, Williams RC. Periodontal regeneration with bioresorbable membranes. Curr Opin Periodontol. 1994:157-67.
citation: Gray JL, Hancock EB. Guided tissue regeneration. Nonabsorbable barriers. Dent Clin North Am. 1998 Jul;42(3):523-41.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Aichelmann-Reidy ME, Yukna RA. Bone replacement grafts. The bone substitutes. Dent Clin North Am. 1998 Jul;42(3):491-503.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.