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

Furcation Defects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04443972
• Other study ID #: Furcation invlvement
• Status: Completed
• Phase: N/A
• Start date: April 12, 2018
• Est. completion date: February 4, 2020

Study information

• Verified date: June 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 4, 2020
• Est. primary completion date: July 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Furcation Defects

Intervention

Other:
• PD VitalOs cement®
PD VitalOs cement®* is a synthetic bone grafting cement designed for bone void filling and bone regeneration in dental surgery
• Hydroxyapatite bone graft
a bioceramic bone substitute, providing a scaffold for bone deposition
• biodegardable collagen membrane
provide efficacious barriers that were interposed between the flap and root surface.

Locations

Country	Name	City	State
Egypt	outpatient clinic of oral medicine department, faculty of dentistry, Alexandria university	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman	Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	change in radiographic bone level (RBL)		at basline, 3 and 6 months
Secondary	change in optical density(OD)		at basline, 3 and 6 months