Immediate Implants in Maxillary Premolar Region Using Xenograft vs Allograft

NCT03716323 | Unknown DMC

• 1 other identifier: CairoMOImplant
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

Immediate implant placement has the disadvantage of difficulty in obtaining primary stability, lack of adequate soft tissue coverage and also the control of the implant position is difficult in addition to the cost of the graft. Autogenous bone graft is considered to be the golden standard for grafting as it has osteoconductive , osteoinductive and osteogenic functions , however it has the problems of donor site morbidity , the need for two surgeries as well as post operative swelling and discomfort of the patient , so alternative bone grafts as allografts and xenografts, has been introduced.

Conditions

Badly Broken Maxillary Premolars Indicated for Extraction

Outcome Measures

Primary Outcomes (1)

• Marginal Bone Loss

  The amount of marginal bone loss will be measured using cone beam computed tomography

  6 months

Study Arms (1)

immediate premolar implant with xenograft and allograft

EXPERIMENTAL

Immediate Implant Placement in Maxillary Premolar zone with grafting the jumping gap using xenograft and allograft

Device: immediate premolar implant with xenograft and allograft

Interventions

immediate premolar implant with xenograft and allograft DEVICE

* A peritome will be used for atraumatic extraction of remaining roots. * The extraction socket will be evaluated for absence of any fenestration or granulation tissues. * Copious normal saline irrigation and curettage will be performed. * In the study group: Immediate implant insertion following standard manufacturer's recommended surgical protocol followed by grafting the jumping gap with cortico-cancellous allograft (MinerOss®, BioHorizons, USA) * In the control group: Immediate implant insertion following standard manufacturer's recommended surgical protocol followed by grafting the jumping gap with anorganic bovine bone mineral xenograft (Bio-Oss®, Geistlich, USA)

immediate premolar implant with xenograft and allograft

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients with badly broken teeth in upper premolar zone indicated for extraction, presence of at least 3 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.
• 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

MeSH Terms

Interventions

Transplantation, Heterologous; Transplantation, Homologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Central Study Contacts

Ahmed M Abdallah, BDS

CONTACT

+201272702226; ahmed.m.abdallah@outlook.com

Mohamed Mounir, PhD

CONTACT

+201001505798; zokasur@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 21, 2018
• First Posted: October 23, 2018
• Study Start: November 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: November 1, 2019
• Last Updated: October 23, 2018

Record last verified: 2018-10