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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Injectable Beta- Tricalcium Phosphate as an Occlusive Barrier Membrane in Treatment of Grade ii Furcation Involvement (Clinical and Radiographic Study)

Conditions
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Furcation Defects

Intervention / Treatment
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* Other: PD VitalOs cement®
* Other: Hydroxyapatite bone graft
* Other: biodegardable collagen membrane


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD VitalOs cement® alone<br>class II furcation defects that will be treated with PD VitalOs cement® alone | Other: PD VitalOs cement®<br>* PD VitalOs cement®* is a synthetic bone grafting cement designed for bone void filling and bone regeneration in dental surgery<br>|
| Experimental: PD VitalOs cement® plus Bone graft and membrane<br>PD VitalOs cement® and Hydroxyapatite bone graft and biodegradable collagen membrane in the treatment of class II furcation defects. | Other: PD VitalOs cement®<br>* PD VitalOs cement®* is a synthetic bone grafting cement designed for bone void filling and bone regeneration in dental surgery<br>Other: Hydroxyapatite bone graft<br>* a bioceramic bone substitute, providing a scaffold for bone deposition<br>Other: biodegardable collagen membrane<br>* provide efficacious barriers that were interposed between the flap and root surface.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 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) | at 3 weeks and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in radiographic bone level (RBL) |  | at basline, 3 and 6 months | 
| change in optical density(OD) |  | at basline, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Grade II Furcation defects