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

NCT04443972 | Completed DMC

• 1 other identifier: Furcation invlvement
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Furcation Defects

Keywords

Grade II Furcation defects

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• change in radiographic bone level (RBL)

  at basline, 3 and 6 months

• change in optical density(OD)

  at basline, 3 and 6 months

Study Arms (2)

PD VitalOs cement® alone

EXPERIMENTAL

class II furcation defects that will be treated with PD VitalOs cement® alone

Other: PD VitalOs cement®

PD VitalOs cement® plus Bone graft and membrane

EXPERIMENTAL

PD VitalOs cement® and Hydroxyapatite bone graft and biodegradable collagen membrane in the treatment of class II furcation defects.

Other: PD VitalOs cement®; Other: Hydroxyapatite bone graft; Other: biodegardable collagen membrane

Interventions

PD VitalOs cement® OTHER

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

PD VitalOs cement® alone; PD VitalOs cement® plus Bone graft and membrane

Hydroxyapatite bone graft OTHER

a bioceramic bone substitute, providing a scaffold for bone deposition

PD VitalOs cement® plus Bone graft and membrane

biodegardable collagen membrane OTHER

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

PD VitalOs cement® plus Bone graft and membrane

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead
• Alexandria University: collaborator

Study Sites (1)

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

Alexandria, Egypt

Location

Related Publications (28)

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MeSH Terms

Conditions

Furcation Defects

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ahmed Hosny Elsayed, BDS

  Alexandria University

  PRINCIPAL INVESTIGATOR

• shahira Ali El Damaty, PHD

  Alexandria University

  STUDY DIRECTOR

• Gehan Sherif Kotry, PHD

  Alexandria University

  STUDY DIRECTOR

• Rania Abd El Aziz Fahmy, PHD

  Alexandria University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: June 20, 2020
• First Posted: June 23, 2020
• Study Start: April 12, 2018
• Primary Completion: July 10, 2019
• Study Completion: February 4, 2020
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)