Soft Tissue Esthetic With Autogenous Dentin Chips and Immediate Implantation Versus Conventional Immediate Implantation With Xenograft in Thin Buccal Bone

Crestal Bone Loss Clinical Trial

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 )

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03544580
• Other study ID #: CEBD-CU-2018-05-01
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: April 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 30, 2020
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crestal Bone Loss

Intervention

Procedure:
• immediate implant with dentine chips
Using dentin chips
• conventional immediate implant
using xenograft

Locations

Country	Name	City	State
Egypt	Cherine Emad Mahmoud Mohamed Hamada	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soft tissue esthetics	pink esthetic score will be taken by photos from the day of surgery till 12 months postoperatively.; The PES will evaluate the mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, and root convexity/ soft tissue color and texture at the facial aspect of the implant site as five variables. A score of 2, 1, or 0 is assigned to each of five PES parameters. Thus, in case of an implant restoration, a maximum total PES of 10 is possible	12 months