Immediate Implant Placement With Platlet Rich Fibrin as Space Filling Material Versus the Use of Deprotienized Bovine Bone (Tutogen) in Maxillary Premolars.

Immediate Implant Placement With Platlet Rich Fibrin as Space Filling Material Versus the Use of Deprotienized Bovine Bone (Tutogen) in Maxillary Premolars. A Randomized Controlled Clinical Trial

20 subjects suffering from non restorable maxillary premolar teeth will be randomly devided into two groups. the selected teeth will be extracted and immeiate implants will be placed in all subjects. the first group will recieve deprotienized bovine bone (tutogen) to fill the buccal space between the implant and the bone, the second group will recieve platlet rich fibrin to fill the buccal space between the implant and the bone

Study Overview

• Status: Unknown
• Conditions: Immediate Dental Implant
• Intervention / Treatment: Procedure: deprotienized bovine bone (tutogen); Procedure: platelet rich fibrin

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• non restorable maxillary premolars non smoker free from any systemic disease or medication that could impair normal bone healing

Exclusion Criteria:

• any systemic disease that could affect bone healing patient with lesion related to the surgical site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: platelet rich fibrin; immediate implant grafting	Procedure: deprotienized bovine bone (tutogen)
Active Comparator: deprotienized bovine bone (tutogen); immediate implant grafting	Procedure: platelet rich fibrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient morbidity	patient pain level on pain scale using pain chart	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
crestal bone loss	radiographic analysis computing amount of crestal bone loss around implants using cone beam computed tomography	3 months
implants stability quotient	implant stability measured using resonance frequency analysis	3 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (Actual): June 12, 2017

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 10, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: cebc.Cairouni

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No