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

• Sponsor: Cairo University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03183349
• Collaborator: (none)
• Enrollment: 20
• Arms: 2
• Anticipated Duration (Months): 12

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Immediate Dental Implant	Procedure: deprotienized bovine bone (tutogen); Procedure: platelet rich fibrin	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Jul 1, 2016
• Anticipated Primary Completion Date: Jun 1, 2017
• Anticipated Study Completion Date: Jul 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Patient morbidity [14 days]

   patient pain level on pain scale using pain chart

Secondary Outcome Measures

1. crestal bone loss [3 months]

   radiographic analysis computing amount of crestal bone loss around implants using cone beam computed tomography

2. implants stability quotient [3 months]

   implant stability measured using resonance frequency analysis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed mohamed awad elbrashy, Principal Investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT03183349
• Other Study ID Numbers: cebc.Cairouni
• First Posted: Jun 12, 2017
• Last Update Posted: Jun 14, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 14, 2017