NCT04814160

Brief Summary

Objective: To compare the use of autogenous bone graft versus autogenous bone graft mixed with bioactive glass bone graft in the treatment of maxillary anterior horizontal bone defects by ridge splitting technique combined with simultaneous implant placement. Materials and methods: Twenty-two patients were divided randomly into two groups; control group and study group. In control group, bone expansion was performed and autogenous bone was used to augment the intercortical bone defect. In study group, bone expansion was performed and autogenous bone mixed with bioactive glass was used to augment the intercortical bone defect. In both groups, the implants were inserted simultaneously with ridge splitting. 6 months after implant placement, the mean bone width and alveolar bone loss values were evaluated. Statistical analysis using paired Student's t- test to compare results within the same group of patients, whereas, independent samples t-test was used to compare variables between the two groups

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

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

April 17, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2021

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
Last Updated

May 4, 2021

Status Verified

May 1, 2021

Enrollment Period

12 months

First QC Date

March 16, 2021

Last Update Submit

May 1, 2021

Conditions

Horizontal Alveolar Ridge Deficiency

Keywords

Ridge splitdental implantpiezosurgerybioactive glassautogenous bone

Outcome Measures

Primary Outcomes (3)

  • Clinical measurements of pain intensity

    pain intensity verbal rating scale either mild, moderate or sever

    6 months

  • Clinical incidence of implants mobility

    Implants mobility

    6 months

  • measuring the survival rates

    survival rates of implants

    6 months

Secondary Outcomes (1)

  • radiographic results of bone width and height

    6 months

Study Arms (2)

autogenous bone graft

ACTIVE COMPARATOR

autogenous bone graft for augmenting bone defects around dental implants placed simultaneously with ridge splitting

Procedure: autogenous bone graft

mix of bioactive glass and autogenous bone graft

EXPERIMENTAL

1:1 mix of bioactive glass and autogenous bone graft for augmenting bone defects around dental implants placed simultaneously with ridge splitting

Procedure: mixture of bioactive glass and autogenous bone graft

Interventions

mixture of bioactive glass and autogenous bone graftPROCEDURE

bone expansion was performed and autogenous bone mixed with bioactive glass was used to augment the intercortical bone defect after ridge splitting and simultaneous dental implants

mix of bioactive glass and autogenous bone graft
autogenous bone graftPROCEDURE

bone expansion was performed and autogenous bone alone was used to augment the intercortical bone defect after ridge splitting and simultaneous dental implants

autogenous bone graft

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • good general health at the time of surgery
  • at least 3months postextraction healing period
  • horizontally compromised maxillary anterior alveolar ridges (at least 3mm bone width and 13mm bone vertical height).

You may not qualify if:

  • vertical bone defect
  • thick labial cortex with less cancellous bone inside
  • obvious undercut on the labial/buccal side
  • uncontrolled periodontal conditions
  • history of radiotherapy in the head and neck region
  • uncontrolled diabetes mellitus or other systematic disorders
  • smokers
  • pregnancy
  • non-compliant patients
  • allergic reaction to the used medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry, kafrelsheikh University

Kafr ash Shaykh, 214312, Egypt

Location

Related Publications (1)

  • Elamrousy W, Osama M, Issa DR. Autogenous Bone and Bioactive Glass around Implants Placed Simultaneously with Ridge Splitting for the Treatment of Horizontal Bony Defects: A Randomised Clinical Trial. Int J Dent. 2021 Jul 28;2021:2457328. doi: 10.1155/2021/2457328. eCollection 2021.

    PMID: 34367287DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of oral medicine and periodontology

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 24, 2021

Study Start

April 17, 2020

Primary Completion

April 10, 2021

Study Completion

April 15, 2021

Last Updated

May 4, 2021

Record last verified: 2021-05

Locations

EG(1)