An interventional study of PD VitalOs cement® and Hydroxyapatite bone graft in Furcation Defects, sponsored by Hams Hamed Abdelrahman. Completed at 1 site in Egypt. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-23.
Sponsored by Hams Hamed Abdelrahman · Not applicable, Interventional, and Treatment
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.
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.
42 studies on the registry are indexed under Furcation Defects; 13 are open to participants now.
This study's enrollment of 14 is below the median of 27 across 38 interventional studies indexed under Furcation Defects.
Browse Furcation Defects studies →Hams Hamed Abdelrahman is the lead sponsor of 111 studies on the registry; 9 are open to participants now.
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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.
Exclusion Criteria:
Uncooperative patients regarding oral hygiene measures performance.
class II furcation defects that will be treated with PD VitalOs cement® alone
Other: PD VitalOs cement®
PD VitalOs cement® and Hydroxyapatite bone graft and biodegradable collagen membrane in the treatment of class II furcation defects.
Other: PD VitalOs cement® · Other: Hydroxyapatite bone graft · Other: biodegardable collagen membrane
PD VitalOs cement®\* is a synthetic bone grafting cement designed for bone void filling and bone regeneration in dental surgery
a bioceramic bone substitute, providing a scaffold for bone deposition
provide efficacious barriers that were interposed between the flap and root surface.
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.
Time frame: at 3 weeks and 6 weeks
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)
Time frame: at 3 weeks and 6 weeks
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)
Time frame: at 3 weeks and 6 weeks
change in radiographic bone level (RBL)
Time frame: at basline, 3 and 6 months
change in optical density(OD)
Time frame: at basline, 3 and 6 months
Plan to share: No
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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