The Evaluation Of Bone Width Gain Following Split Crest Technique With Or Without Platelet Rich Fibrin( PRF)

NCT03037125 | Completed

• 1 other identifier: PERIO 3:7:3
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Split crest technique is a technique for horizontal bone augmentation used in case of narrow alveolar ridges as an alternative to the more aggressive techniques such as onlay bone grafting, guided bone regeneration (GBR) and distraction osteogenesis The study goal is to evaluate whether if there will be any benefit of using platelet rich fibrin (PRF) with the split crest technique regarding bone width gain and healing response in comparison with split crest technique alone, where PRF is considered an autologous, growth factor containing material which is easy to collect and is of low cost.

Conditions

Ridge Deficiency

Outcome Measures

Primary Outcomes (1)

• Bone width gain

  6 months

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Split crest without PRF

Procedure: Split Crest without PRF

Intervention Arm

EXPERIMENTAL

Split crest with PRF

Procedure: Split Crest with PRF

Interventions

Split Crest with PRF PROCEDURE

Narrow ridges are split to increase the ridge width and immediate implants are placed with PRF closing the gap

Intervention Arm

Split Crest without PRF PROCEDURE

Narrow ridges are split to increase the ridge width and immediate implants are placed without grafting

Control Arm

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with at least one missing tooth in the maxillary region
• All the selected patients have a bucco-palatal width of the edentulous alveolar ridge from 3.5-5.5mm.
• All the selected patients have at least 12 mm residual bone height at the edentulous area
• The recipient site of the implant should be free from any pathological conditions.
• No diagnosed bone disease or medication known to affect bone metabolism.
• Patients who are cooperative, motivated, and hygiene conscious.

You may not qualify if:

• Patients unable to undergo minor oral surgical procedures.
• Patients with a history of drug abuse or catabolic drugs.
• Patients with a history of psychiatric disorder.
• Patients with unrealistic expectations about the esthetic outcome of implant therapy.
• Patients with insufficient vertical inter-arch space, upon centric occlusion, to accommodate the available restorative components.
• Patients in the growth stage with partially erupted teeth.
• Patients who have any systemic condition that may contraindicate implant therapy.
• Patients who have any habits that might jeopardize the osseointegration process, such as smoking and alcoholism.
• Patients with parafunctional habits that produce overload on the implant, such as bruxism and clenching.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of oral and dental medicine, Cairo university

Cairo, 4240310, Egypt

Location

MeSH Terms

Interventions

Prolactin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bachelor

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 31, 2017
• Study Start: March 1, 2017
• Primary Completion: March 15, 2019
• Study Completion: June 1, 2019
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

EG (1)