NCT04266652

Brief Summary

assess and compare the efficacy and safety of autogenous tooth roots for lateral alveolar ridge augmentation with staged implant placement in comparison to autogenous bone block.

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
14

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2018

Typical duration for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

2.6 years

First QC Date

January 29, 2020

Last Update Submit

July 21, 2020

Conditions

Keywords

tooth blockDental implants

Outcome Measures

Primary Outcomes (1)

  • Clinical and radiographic assessment of alveolar bone width following autogenous tooth roots augmentation.

    6 months postoperatively

Secondary Outcomes (1)

  • Histological analysis of remodeled autogenous bone roots 4 months following horizontal ridge augmentation. Histological analysis of remodeled autogenous bone roots 4 months following horizontal ridge augmentation.

    6 months postoperatively

Study Arms (2)

Autogenous bone block

EXPERIMENTAL

the monocortical block grafts were harvested from the retromolar region (i.e. linea oblique) by using of rotating (i.e. carbide burs)

Procedure: autogenous bone block

Tooth block

EXPERIMENTAL

In the first group, a second mucoperiosteal flap was elevated to surgically remove the respective wisdom tooth. After its removal and during the same surgery, the crown was decapitated at the cemento -enamel junction using a rotating carbide bur under gentle sterile saline cooling and the exposed pulp was preserved. The separated tooth root was adapted to match the size and shape of the defect area. To improve ankylosis between the graft and the defect site, the layer of cementum at the respective downward aspects of the root was carefully removed using a diamond bur until the underlying dentin was entirely exposed

Procedure: tooth block

Interventions

tooth blockPROCEDURE

tooth root blocks were used to increase the bone width

Tooth block

autogenous bone block were used to increase the bone width

Autogenous bone block

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Candidate for lateral ridge augmentation
  • Insufficient bone ridge width at the recipient site for implant placement
  • Sufficient bone height at the recipient site for implant placement
  • Healthy oral mucosa, at least 3 mm keratinized tissue.
  • Presence of wisdom teeth free from periapical infection.
  • Missing maxillary or mandibular tooth with moderate horizontal defect (4-8) according to cologne classification

You may not qualify if:

  • \) Patients are systemically free according to Modified Cornell Medical Index 2) smokers patients. 3) Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Abbassia, 11566, Egypt

RECRUITING

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Periodontology, Faculty of Dentistry

Study Record Dates

First Submitted

January 29, 2020

First Posted

February 12, 2020

Study Start

January 6, 2018

Primary Completion

August 15, 2020

Study Completion

September 30, 2020

Last Updated

July 22, 2020

Record last verified: 2020-07

Locations