Clinical trial NCT03544580: Soft Tissue Esthetic With Autogenous Dentin Chips and Immediate Implantation Versus Conventional Immediate Implantation With Xenograft in Thin Buccal Bone
Official title: Soft Tissue Esthetic With Autogenous Dentin Chips and Immediate Implantation Versus Conventional Immediate Implantation With Xenograft in Thin Buccal Bone: (Randomized Controlled Clinical Trial )
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crestal Bone Loss
Keywords: dentin
immediate implant
buccal bone resorption
crestal bone loss
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After tooth extraction, host bone resorption and atrophy of alveolar ridge may be observed. Bone resorption occurs specially in incisors and premolar area of jaw in region of thin buccal bone that may lead to change in contour. Total clinical bone loss height approximately 2-5 mm at first 6 months may be observed in vertical dimension , after 12 months alveolar ridge may lose up to 50 % of its width.

Detailed description: Recently augmentation with bone grafting became one of the most common techniques surgically ; progressive bone resorption may be prevented by using augmentation procedures with use of graft materials. The gold standard in regenerative procedures is autogenous bone graft because of osteoinduction , osteoconduction and osteointergration properties required in regeneration. In autogenous bone graft there is need for a second surgical site , donor site morbidity and limited availability will lead to challenge for alternative bio-materials.

Extracted healthy non functional teeth from human are considered to be a dental waste all over the world. High proportion of extracted sockets are left untreated for physiological healing. Inadequate or failure of bone healing in sockets has been seen due to absence of bone graft material. Stem cells, matrix , trace metal ions and growth factors are rich in human tooth. Bone and dentin tissue structure are different but ratio of components is similar (mineral 70% , collagen 20% and body fluid 10% by weight). Dentin after demineralization is mainly composed of type 1 collagen 95% and non collagenous proteins as growth factors.

Eligibility criteria: Inclusion Criteria:

* Patient related :

  * Patient who only need to restore this single tooth.
  * Good oral hygiene
  * Systemically healthy (free from any systemic diseases)

Site related :

* Hopeless tooth (nonrestorable, badly broken, endodontically treated) indicated for extraction and immediate implant placement
* Esthetic area with thin buccal bone
* Having periapical bone more than 3mm for primary stability

Exclusion Criteria:

* Patient related :

  * Smokers
  * Pregnant woman

Site related

* Teeth that have to be extracted due to advanced periodontal bone loss
* Trauma in aesthetic area
* Periapical infection.

Primary outcomes:
measure: Soft tissue esthetics
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cherine Emad Mahmoud Mohamed Hamada
Study officials:
References: