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NCT Number: NCT04443972

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

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.

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Key information

Conditions

Furcation Defects Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

outpatient clinic of oral medicine department, faculty of dentistry, Alexandria university

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PD VitalOs cement®

Other

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

Hydroxyapatite bone graft

Other

a bioceramic bone substitute, providing a scaffold for bone deposition

biodegardable collagen membrane

Other

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

Primary outcomes

  1. change in plaque index scores (PI) according to Silness and Löe.

    Time frame: 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.

  2. change in probing Pocket Depth(PPD)

    Time frame: 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)

  3. change in clinical Attachment Level

    Time frame: 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 outcomes

  1. change in radiographic bone level (RBL)

    Time frame: at basline, 3 and 6 months

  2. change in optical density(OD)

    Time frame: at basline, 3 and 6 months

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Collaborators

  • Alexandria University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 23, 2020
Registry last updated
Jun 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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