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
About this trial
This is an interventional treatment trial for Furcation Defects focused on measuring Grade II Furcation defects
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.
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
NCT ID
NCT04443972
First Posted
June 20, 2020
Last Updated
June 20, 2020
Sponsor
Hams Hamed Abdelrahman
Collaborators
Alexandria University
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
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Evaluation of Injectable Beta-tricalcium Phosphate Clinically in Treatment of Grade II Furcation Involvement
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