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

NCT03544580 | Completed DMC

• 1 other identifier: CEBD-CU-2018-05-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Crestal Bone Loss

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

immediate implant with dentin chips

EXPERIMENTAL

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

immediate implant with xenograft

ACTIVE COMPARATOR

after surgical removal of entire badly decayed tooth we immediately put implant and in jumping gap we use xenograft

Procedure: conventional immediate implant

Interventions

immediate implant with dentine chips PROCEDURE

Using dentin chips

Also known as: Conventional immediate implantation

immediate implant with dentin chips

conventional immediate implant PROCEDURE

using xenograft

Also known as: immediate implantation with xenograft

immediate implant with xenograft

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cherine Emad Mahmoud Mohamed Hamada

Giza, 12566, Egypt

Location

MeSH Terms

Interventions

Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: June 4, 2018
• Study Start: August 1, 2018
• Primary Completion: October 30, 2019
• Study Completion: December 30, 2020
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

EG (1)