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

• ClinicalTrials.gov Identifier: NCT03544580
• Recruitment Status: Completed
• First Posted: June 4, 2018
• Last Update Posted: April 27, 2021
• Sponsor: Cairo University
• Information provided by (Responsible Party): Cherine Emad Mahmoud Mohamed Hamada, Cairo University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Crestal Bone Loss	Procedure: immediate implant with dentine chips; Procedure: conventional immediate implant	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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 )
• Actual Study Start Date: August 1, 2018
• Actual Primary Completion Date: October 30, 2019
• Actual Study Completion Date: December 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: immediate implant with dentin chips; using the tooth structure presented in socket either as remaining root or as unrestorable tooth structure remove all periodontal ligaments & scraping all enamel & cementum using a stone also to cut it into slices then putting it in acid to demineralize the dentine ; then using a bone mill to transform dentine into small particles or chips to be used in jumping gap between implant & thin buccal bone	Procedure: immediate implant with dentine chips; Using dentin chips; Other Name: Conventional immediate implantation
Active Comparator: immediate implant with xenograft; after surgical removal of entire badly decayed tooth we immediately put implant and in jumping gap we use xenograft	Procedure: conventional immediate implant; using xenograft; Other Name: immediate implantation with xenograft

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Egypt

Cherine Emad Mahmoud Mohamed Hamada

Giza, Egypt, 12566

Sponsors and Collaborators

Cairo University

More Information

• Responsible Party: Cherine Emad Mahmoud Mohamed Hamada, principal investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT03544580
• Other Study ID Numbers: CEBD-CU-2018-05-01
• First Posted: June 4, 2018
• Last Update Posted: April 27, 2021
• Last Verified: April 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cherine Emad Mahmoud Mohamed Hamada, Cairo University:

dentin; immediate implant; buccal bone resorption; crestal bone loss