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One-stage Versus Two-stage Inverted U-shaped Ridge Splitting

Status

Completed

Conditions

Maxillary Ridge Augmentation

Treatments

Procedure: Two-stage ridge splitting with implant placement
Procedure: One stage ridge splitting with simultaneous implant placement

Study type

Interventional

Funder types

Other

Identifiers

NCT04720495
Ridge_splitting

Details and patient eligibility

About

Fourteen patients having anterior maxillary undercut defect were selected to match a list of inclusion and exclusion criteria.

The participants were randomly allocated using a computer system into two groups:

Group A undergo inverted U-shaped maxillary ridge splitting using piezotomes with simultaneous implant placement in the same surgery.

Group B undergo inverted U-shaped maxillary ridge splitting as a first stage and after four weeks, ridge expansion and implant placement will be performed with only envelop flap.

Assessment included measurements of bone gain at the undercut defect and bone density labial to implants in each group from the cone-beam computed tomography

Enrollment

14 patients

Sex

All

Ages

20 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

  • Adult patients (20-45) years of age with no sex predilection
  • At least one tooth missing in the anterior maxilla
  • The presence of a labial undercut >2 mm in thickness which is not able to house an implant
  • The presence of adequate bone width near the alveolar bone crest
  • The absence of a vertical bone defect.

Exclusion criteria

  • History of any systemic disease that would contraindicate surgery example uncontrolled diabetes.
  • Pregnancy or lactation.
  • Long-term amino-bisphosphonate therapy.
  • Smoking more than 10 cigarettes per day.
  • Alcohol or drug abuse.
  • Uncontrolled periodontal disease.
  • Active infection.
  • Inadequate inter-incisal space.
  • Bruxism or clenching.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

14 participants in 2 patient groups

One stage ridge splitting
Active Comparator group
Treatment:
Procedure: One stage ridge splitting with simultaneous implant placement
Two-stage ridge splitting
Experimental group
Treatment:
Procedure: Two-stage ridge splitting with implant placement

Trial contacts and locations

1

There are currently no registered sites for this trial.

Timeline

Last updated: Jan 22, 2021

Start date

Oct 01, 2019 • 5 years ago

End date

Sep 30, 2020 • 4 years ago

Today

Apr 30, 2025

Sponsor of this trial

Data sourced from clinicaltrials.gov