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Completed

NCT Number: NCT03544580

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

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.

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Key information

Conditions

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cherine Emad Mahmoud Mohamed Hamada

Giza, 12566, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

immediate implant with dentine chips

Procedure

Using dentin chips

Other names: Conventional immediate implantation

conventional immediate implant

Procedure

using xenograft

Other names: immediate implantation with xenograft

Primary outcomes

  1. Soft tissue esthetics

    Time frame: 12 months

    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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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 )

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 4, 2018
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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