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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04443972
Enrollment
14
Registered
2020-06-23
Start date
2018-04-12
Completion date
2020-02-04
Last updated
2020-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Furcation Defects

Keywords

Grade II Furcation defects

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.

Interventions

OTHERPD VitalOs cement®

PD VitalOs cement®\* is a synthetic bone grafting cement designed for bone void filling and bone regeneration in dental surgery

OTHERHydroxyapatite bone graft

a bioceramic bone substitute, providing a scaffold for bone deposition

OTHERbiodegardable collagen membrane

provide efficacious barriers that were interposed between the flap and root surface.

Sponsors

Alexandria University
CollaboratorOTHER
Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
change in plaque index scores (PI) according to Silness and Löe.at 3 weeks and 6 weeksScore 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 weeksThe 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 Levelat 3 weeks and 6 weeksThe 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

MeasureTime frame
change in radiographic bone level (RBL)at basline, 3 and 6 months
change in optical density(OD)at basline, 3 and 6 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026