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

Not Applicable

Completed

• Conditions: Furcation Defects
• Interventions: Other: PD VitalOs cement®; Other: Hydroxyapatite bone graft; Other: biodegardable collagen membrane

• Registration Number: NCT04443972
• Lead Sponsor: Hams Hamed Abdelrahman

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.

Study Timeline

• Study Start: 2018-04-12
• Primary Completion: 2019-07-10
• Study Completion: 2020-02-04
• Status Verified: 2020-06
• Study First Submitted: 2020-06-20
• Study First Submitted QC: 2020-06-20
• Last Update Submitted: 2020-06-20
• Study First Posted: 2020-06-23
• Last Update Posted: 2020-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PD VitalOs cement® alone	PD VitalOs cement®	class II furcation defects that will be treated with PD VitalOs cement® alone
PD VitalOs cement® plus Bone graft and membrane	biodegardable collagen membrane	PD VitalOs cement® and Hydroxyapatite bone graft and biodegradable collagen membrane in the treatment of class II furcation defects.
PD VitalOs cement® plus Bone graft and membrane	PD VitalOs cement®	PD VitalOs cement® and Hydroxyapatite bone graft and biodegradable collagen membrane in the treatment of class II furcation defects.
PD VitalOs cement® plus Bone graft and membrane	Hydroxyapatite bone graft	PD VitalOs cement® and Hydroxyapatite bone graft and biodegradable collagen membrane in the treatment of class II furcation defects.

Primary Outcome Measures

Name	Time	Method
change in clinical Attachment Level	at 3 weeks and 6 weeks	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 plaque index scores (PI) according to Silness and Löe.	at 3 weeks and 6 weeks	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)	at 3 weeks and 6 weeks	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

Name	Time	Method
change in optical density(OD)	at basline, 3 and 6 months
change in radiographic bone level (RBL)	at basline, 3 and 6 months

Trial Locations

Locations (1)

outpatient clinic of oral medicine department, faculty of dentistry, Alexandria university; 🇪🇬 Alexandria, Egypt