Immediate Implants in Maxillary Premolar Region Using Xenograft vs Allograft

Badly Broken Maxillary Premolars Indicated for Extraction Clinical Trial

Official title:

Evaluation of Marginal Bone Loss After Immediate Implant Placement in Maxillary Premolar Zone With Allograft Versus Xenograft

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03716323
• Other study ID #: CairoMOImplant
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2018
• Est. completion date: November 2019

Study information

• Verified date: October 2018
• Source: Cairo University
• Contact: Ahmed M Abdallah, BDS
• Phone: +201272702226
• Email: ahmed.m.abdallah[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Allograft bone is obtained from individuals of the same species, derived from human-cadaver bone that has been selected and tested to be free of HIV and transmitted diseases. The most common allograft used is dematerialized freeze-dried bone allograft (DFDBA), provide type I collagen, which comprises most of the organic component of bone. In addition, allograft contains BMPs, which stimulate osteoinduction. There are thirteen proteins have been identified (BMP1-BMP13) which are osteoinductive compounds and stimulate new bone formation. A previous study demonstrated that, a combination of osseous coagulum collected during preparation and freeze-dried bone allograft placed at immediate implant insertion and loading. Xenografts are one of the most successful and widely used grafting materials nowadays as a replacement for autogenous bone grafts. Studies showed that xenografts are very successful because of their osteoconductive properties, their denisty which provides stabilization to the graft and implant and they supply the necessary minerals for bone formation as xenograft don't resorb completely.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: November 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Badly Broken Maxillary Premolars Indicated for Extraction

Intervention

Device:
• immediate premolar implant with xenograft and allograft
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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal Bone Loss	The amount of marginal bone loss will be measured using cone beam computed tomography	6 months