NCT04096209

Brief Summary

Xenografts are graft materials derived from the inorganic portion of animal bones; the most common source is bovine the removal of the organic component are processed to remove their antigenicity, while the remaining inorganic components provide a natural matrix as well as an excellent source of calcium. The disadvantage of xenografts is that they are only osteoconductive and the resorption rate of bovine cortical bone is slow. However leaving the jumping gap empty has been the gold standard for immediate implantation as the formed blood clot will allow bone fill in that area.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

September 30, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

8 months

First QC Date

September 18, 2019

Last Update Submit

September 18, 2019

Conditions

Badly Decayed Teeth

Outcome Measures

Primary Outcomes (1)

  • Implant stability

    implant stability will be measured using osstell

    4-6 months

Study Arms (1)

Graft-less and grafting using xenograft and autograft

EXPERIMENTAL

Extraction of badly decayed teeth with immediate implant placement using graft-less and grafting using autogenous bone and xenograft between the implant and labial socket bone

Device: autograft mixed with xenograft bone

Interventions

autograft mixed with xenograft boneDEVICE

Eligible patients will be randomized in equal proportions between control group (immediate implant placement without bone grafts in the jumping gap) and study group (immediate implant placement with a mixture of Xenograft and autogenous bone placed in the jumping gap). All patients will be evaluated by proper history taking and thorough clinical and radio graphical examination and assessed according to the inclusion and exclusion criteria. Patients of both groups will be subjected to Cone beam Computed tomography (CBCT). Primary impression will be taken, a study model will then be poured and then waxing up will be performed. Patients will be instructed to rinse with chlorhexidine 0.1% mouthwash. Articaine 4% (1:100,000) local anesthesia will be given to the patient. Atraumatic extraction of the tooth or remaining root using No. 15c lancet and periotome

Graft-less and grafting using xenograft and autograft

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age from 20-60 years
  • Both sexes
  • non-restorable maxillary incisors, canine and premolars
  • Good oral hygiene
  • Adequate bone height apical to the alveolus of the failing tooth

You may not qualify if:

  • Systematic disease which affect osseointegration (uncontrolled diabetes, cancer, etc...)
  • Bad oral hygiene
  • Bruxism, clenching, deep bite, edge to edge and abnormal habits
  • Non-treated periodontal diseases
  • Pregnancy and smokers
  • Severe infection
  • Absence of labial plate of bone (Fenestration, dehiscence).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (1)

  • El Ebiary SO, Atef M, Abdelaziz MS, Khashaba M. Guided immediate implant with and without using a mixture of autogenous and xeno bone grafts in the dental esthetic zone. A randomized clinical trial. BMC Res Notes. 2023 Nov 13;16(1):331. doi: 10.1186/s13104-023-06612-8.

    PMID: 37957760DERIVED

Central Study Contacts

Sherine Osama El-Ebiary, BDS

CONTACT

01285594066sherine.ebiary@gmail.com

Mohammed Atef, PhD

CONTACT

01009612708zokasur@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 18, 2019

First Posted

September 19, 2019

Study Start

September 30, 2019

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

September 19, 2019

Record last verified: 2019-09

Locations

EG(1)