search
Back to results

Evaluation of Injectable Beta-tricalcium Phosphate Clinically in Treatment of Grade II Furcation Involvement

Primary Purpose

Furcation Defects

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PD VitalOs cement®
Hydroxyapatite bone graft
biodegardable collagen membrane
Sponsored by
Hams Hamed Abdelrahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Furcation Defects focused on measuring Grade II Furcation defects

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • outpatient clinic of oral medicine department, faculty of dentistry, Alexandria university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PD VitalOs cement® alone

PD VitalOs cement® plus Bone graft and membrane

Arm Description

class II furcation defects that will be treated with PD VitalOs cement® alone

PD VitalOs cement® and Hydroxyapatite bone graft and biodegradable collagen membrane in the treatment of class II furcation defects.

Outcomes

Primary Outcome Measures

change in plaque index scores (PI) according to Silness and Löe.
Score 0 = no plaque in gingival area. Score 1= film of plaque adhering to the free gingival margin and the adjacent area of the tooth, plaque may only be recognized by running a probe across the tooth surface. Score 2= moderate accumulation of soft deposits within the gingival pocket and on the gingival margin and/ or adjacent tooth surface which can be seen by the naked eye. Score 3= abundant of soft matter within gingival pocket and/ or the gingival margin and adjacent tooth surface. The scores from the four surfaces of the tooth were added and divided by (four) to give plaque index for each tooth; the plaque index score for an individual was obtained by adding the indices of the teeth and dividing by the number of the teeth examined.
change in probing Pocket Depth(PPD)
The measurements were carried out to the defects selected using an 0.8 mm thick periodontal probe * with William's calibration, which was marked from (1-10) mm, pocket depth of (1 mm) or less was recorded as (1mm),measurements exceeding (1mm) but less than (2mm) were recorded as (2mm) so that the probing pocket depth was measured to the nearest mm. Probing pocket depth refers to the distance from the gingival margin to the bottom of the pocket. Mesial and distal pockets were measured as well as the furcation from the buccal aspect as close as possible to the contact points, facial and lingual pockets were measured at midline of roots. Efforts were made to insert the probe parallel to the long axis of the roots. Light force was used during the introduction of the probe to the bottom of the pocket, third molars and teeth with enamel projections were excluded. (7)
change in clinical Attachment Level
The measurements were carried out to the defects selected using an 0.8 mm thick periodontal probe * with William's calibration, which was marked from (1-10) mm, pocket depth of (1 mm) or less was recorded as (1mm),measurements exceeding (1mm) but less than (2mm) were recorded as (2mm) so that the probing pocket depth was measured to the nearest mm. Probing pocket depth refers to the distance from the gingival margin to the bottom of the pocket. Mesial and distal pockets were measured as well as the furcation from the buccal aspect as close as possible to the contact points, facial and lingual pockets were measured at midline of roots. Efforts were made to insert the probe parallel to the long axis of the roots. Light force was used during the introduction of the probe to the bottom of the pocket, third molars and teeth with enamel projections were excluded. (7)

Secondary Outcome Measures

change in radiographic bone level (RBL)
change in optical density(OD)

Full Information

First Posted
June 20, 2020
Last Updated
June 20, 2020
Sponsor
Hams Hamed Abdelrahman
Collaborators
Alexandria University
search

1. Study Identification

Unique Protocol Identification Number
NCT04443972
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 12, 2018 (Actual)
Primary Completion Date
July 10, 2019 (Actual)
Study Completion Date
February 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman
Collaborators
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Furcation Defects
Keywords
Grade II Furcation defects

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PD VitalOs cement® alone
Arm Type
Experimental
Arm Description
class II furcation defects that will be treated with PD VitalOs cement® alone
Arm Title
PD VitalOs cement® plus Bone graft and membrane
Arm Type
Experimental
Arm Description
PD VitalOs cement® and Hydroxyapatite bone graft and biodegradable collagen membrane in the treatment of class II furcation defects.
Intervention Type
Other
Intervention Name(s)
PD VitalOs cement®
Intervention Description
PD VitalOs cement®* is a synthetic bone grafting cement designed for bone void filling and bone regeneration in dental surgery
Intervention Type
Other
Intervention Name(s)
Hydroxyapatite bone graft
Intervention Description
a bioceramic bone substitute, providing a scaffold for bone deposition
Intervention Type
Other
Intervention Name(s)
biodegardable collagen membrane
Intervention Description
provide efficacious barriers that were interposed between the flap and root surface.
Primary Outcome Measure Information:
Title
change in plaque index scores (PI) according to Silness and Löe.
Description
Score 0 = no plaque in gingival area. Score 1= film of plaque adhering to the free gingival margin and the adjacent area of the tooth, plaque may only be recognized by running a probe across the tooth surface. Score 2= moderate accumulation of soft deposits within the gingival pocket and on the gingival margin and/ or adjacent tooth surface which can be seen by the naked eye. Score 3= abundant of soft matter within gingival pocket and/ or the gingival margin and adjacent tooth surface. The scores from the four surfaces of the tooth were added and divided by (four) to give plaque index for each tooth; the plaque index score for an individual was obtained by adding the indices of the teeth and dividing by the number of the teeth examined.
Time Frame
at 3 weeks and 6 weeks
Title
change in probing Pocket Depth(PPD)
Description
The measurements were carried out to the defects selected using an 0.8 mm thick periodontal probe * with William's calibration, which was marked from (1-10) mm, pocket depth of (1 mm) or less was recorded as (1mm),measurements exceeding (1mm) but less than (2mm) were recorded as (2mm) so that the probing pocket depth was measured to the nearest mm. Probing pocket depth refers to the distance from the gingival margin to the bottom of the pocket. Mesial and distal pockets were measured as well as the furcation from the buccal aspect as close as possible to the contact points, facial and lingual pockets were measured at midline of roots. Efforts were made to insert the probe parallel to the long axis of the roots. Light force was used during the introduction of the probe to the bottom of the pocket, third molars and teeth with enamel projections were excluded. (7)
Time Frame
at 3 weeks and 6 weeks
Title
change in clinical Attachment Level
Description
The measurements were carried out to the defects selected using an 0.8 mm thick periodontal probe * with William's calibration, which was marked from (1-10) mm, pocket depth of (1 mm) or less was recorded as (1mm),measurements exceeding (1mm) but less than (2mm) were recorded as (2mm) so that the probing pocket depth was measured to the nearest mm. Probing pocket depth refers to the distance from the gingival margin to the bottom of the pocket. Mesial and distal pockets were measured as well as the furcation from the buccal aspect as close as possible to the contact points, facial and lingual pockets were measured at midline of roots. Efforts were made to insert the probe parallel to the long axis of the roots. Light force was used during the introduction of the probe to the bottom of the pocket, third molars and teeth with enamel projections were excluded. (7)
Time Frame
at 3 weeks and 6 weeks
Secondary Outcome Measure Information:
Title
change in radiographic bone level (RBL)
Time Frame
at basline, 3 and 6 months
Title
change in optical density(OD)
Time Frame
at basline, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Hosny Elsayed, BDS
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
shahira Ali El Damaty, PHD
Organizational Affiliation
Alexandria University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gehan Sherif Kotry, PHD
Organizational Affiliation
Alexandria University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rania Abd El Aziz Fahmy, PHD
Organizational Affiliation
Alexandria University
Official's Role
Study Director
Facility Information:
Facility Name
outpatient clinic of oral medicine department, faculty of dentistry, Alexandria university
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16945031
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.
Results Reference
background
PubMed Identifier
14584858
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.
Results Reference
background
PubMed Identifier
9579616
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.
Results Reference
background
PubMed Identifier
10321217
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.
Results Reference
background
PubMed Identifier
9151555
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.
Results Reference
background
PubMed Identifier
8032456
Citation
Mendieta C, Williams RC. Periodontal regeneration with bioresorbable membranes. Curr Opin Periodontol. 1994:157-67.
Results Reference
background
PubMed Identifier
9700453
Citation
Gray JL, Hancock EB. Guided tissue regeneration. Nonabsorbable barriers. Dent Clin North Am. 1998 Jul;42(3):523-41.
Results Reference
background
PubMed Identifier
10715922
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.
Results Reference
background
PubMed Identifier
12593590
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.
Results Reference
background
PubMed Identifier
9084307
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.
Results Reference
background
PubMed Identifier
1058213
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.
Results Reference
background
PubMed Identifier
277674
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.
Results Reference
background
PubMed Identifier
2831333
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.
Results Reference
background
PubMed Identifier
10632525
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.
Results Reference
background
PubMed Identifier
10052766
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.
Results Reference
background
PubMed Identifier
9019484
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.
Results Reference
background
PubMed Identifier
12888990
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.
Results Reference
background
PubMed Identifier
7918904
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.
Results Reference
background
PubMed Identifier
8358939
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.
Results Reference
background
PubMed Identifier
9700451
Citation
Aichelmann-Reidy ME, Yukna RA. Bone replacement grafts. The bone substitutes. Dent Clin North Am. 1998 Jul;42(3):491-503.
Results Reference
background
PubMed Identifier
775048
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.
Results Reference
background
PubMed Identifier
8277399
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.
Results Reference
background
PubMed Identifier
8005773
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.
Results Reference
background
PubMed Identifier
10863370
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.
Results Reference
background
PubMed Identifier
2319003
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.
Results Reference
background
PubMed Identifier
4500182
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.
Results Reference
background
PubMed Identifier
14158464
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.
Results Reference
background
PubMed Identifier
4237475
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.
Results Reference
background

Learn more about this trial

Evaluation of Injectable Beta-tricalcium Phosphate Clinically in Treatment of Grade II Furcation Involvement

We'll reach out to this number within 24 hrs