Evaluation of Marginal Bone Loss After Immediate Implant Placement in Maxillary Esthetic Zone With Nanobone Versus Xenograft

NCT03536260 | Unknown

• 1 other identifier: FarahatMBL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Immediate implant placement has a success rate from 94-100 % . After tooth extraction there is a loss in the horizontal and vertical dimension by about 3-6 mm and 1-2 mm respectively and alveolar crest resorption of about 44% especially through 6 months after extraction. After immediate implant placement there is usually a void between the implant and the socket walls which is called jumping distance or gap which may heal spontaneously or need bone graft to bridge the space. If the gap is 1-2 mm it may heal spontaneously more than that this will need bone graft. There is no evidence that the graft impairs osseointegration Development of artificial bone has increasingly progressed in the last few years. Nanobone "nanocrystalline hydroxyapatite embedded in a porous silica gel matrix bone graft is introduced which has osseoconductive and biomimetic properties .the sub-micron modification in the bone substitute will enhance osteogenic property. It bind to the bone by stimulation of osteoblast activity and enhance growth factors which improve bone healing and provide more strength and stability to the implant.

Conditions

Implant Placement in Maxillary Esthetic Zone

Outcome Measures

Primary Outcomes (1)

• Measurement of Crestal Bone Loss in grafted socket

  3 months after implant placement

Study Arms (2)

Immediate implant with Xenograft

ACTIVE COMPARATOR

Device: Implant with Xenograft

Immediate implant with Nanobone

ACTIVE COMPARATOR

Device: Implant with NanoBone graft

Interventions

Implant with NanoBone graft DEVICE

Using of NanoBone graft to fill the gap in the socket after immediate implant placement

Immediate implant with Nanobone

Implant with Xenograft DEVICE

Using of Xenograft to fill the gap in the socket after immediate implant placement

Immediate implant with Xenograft

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with badly broken teeth in upper esthetic zone indicated for extraction, presence of at least 4 mm of bone beyond the root apex to guarantee implant primary stability, implant placement within the alveoli confines.
• Both sexes.
• No intraoral soft and hard tissue pathology.
• No systemic condition that contraindicate implant placement.

You may not qualify if:

• Presence of fenestrations or dehiscence of the residual bony Walls after extraction.
• Heavy smokers more than 20 cigarettes per day .(24)
• Patients with systemic disease that may affect normal healing.
• Psychiatric problems
• Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry , Cairo university

Cairo, Egypt

Location

MeSH Terms

Interventions

Mutagenesis, Insertional; Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Protein Engineering; Genetic Engineering; Genetic Techniques; Investigative Techniques; Mutation; Genetic Variation; Genetic Phenomena; Mutagenesis; Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: May 24, 2018
• Study Start: July 1, 2017
• Primary Completion: May 30, 2018
• Study Completion: June 30, 2018
• Last Updated: May 24, 2018

Record last verified: 2018-05

Locations

EG (1)