Guided bone regeneration (GBR) for Horizontal Ridge Deficiency

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Michigan School of Dentistry, Ann Arbor, MI
Horizontal Ridge Deficiency
Guided bone regeneration (GBR) - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new technique for wound healing is better than the standard technique.

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Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Guided bone regeneration (GBR) will improve 1 primary outcome in patients with Horizontal Ridge Deficiency. Measurement will happen over the course of 6 months.

6 months
Ridge width changes

Trial Safety

Trial Design

2 Treatment Groups

Closed Wound
1 of 2
Open Wound
1 of 2
Active Control
Experimental Treatment

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Guided Bone Regeneration (GBR) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Open Wound
Procedure
After horizontal bone grafting, the wound where the graft was attached to the bone will be filled with a type of tissue (the amnion-chorion membrane) taken from a placenta and will be left partially open to heal.
Closed Wound
Procedure
After horizontal bone grafting, the wound where the graft was attached to the bone will be filled with collagen tissue and stitched closed while it heals.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Who is running the study

Principal Investigator
S. Y.
Prof. Shan-Huey Yu, Clinical Assistant Professor
University of Michigan

Closest Location

University of Michigan School of Dentistry - Ann Arbor, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient needs horizontal bone ridge augmentation (widening of the bone) prior to implant placement, as determined clinically and radiographically. show original
of implant placement The patient should have enough bone height at the implant site to ensure a successful implant placement. show original
You must be 21 years old or older to purchase this item. show original
Be missing at least one back tooth in the lower jaw for at least three months. show original

Patient Q&A Section

What are the signs of horizontal ridge deficiency?

"Horizontal ridge deficiency often has many signs and symptoms. The main manifestations are deformity of maxillary and mandibular arch, overjumping of maxillary and mandibular third molars, and a proclined incisal third molar. A thorough oral and radiological evaluation is necessary to avoid unnecessary and even harmful orthodontic treatment of teeth." - Anonymous Online Contributor

Unverified Answer

What is horizontal ridge deficiency?

"Horizontal and vertical bone defects have a similar rate of incorporation into the adjacent bone in humans. Results from a recent clinical trial, no benefit was observed by a single application of autograft in horizontal or vertical defects." - Anonymous Online Contributor

Unverified Answer

What causes horizontal ridge deficiency?

"Horizontal ridge deficiency is a well-described complication of cleft palate repair. However, the mechanism of cause may be either local or systemic. A combination of local and systemic alterations of cleft palate repair may explain the defect in the ridge." - Anonymous Online Contributor

Unverified Answer

What are common treatments for horizontal ridge deficiency?

"Some horizontal ridge deficiencies can be surgically corrected with a technique called sagittal split ramus osteotomy (SSRO), which is a minimally-invasive procedure. There were no complications associated with SRSO. However, the indications for SRSO vs. ORIF must be carefully analyzed to obtain the right treatment for each case." - Anonymous Online Contributor

Unverified Answer

How many people get horizontal ridge deficiency a year in the United States?

"Half of all the reported incidences with this deficiency are actually Type I. This type of incidences could hardly have been treated by surgeons with modern surgical techniques." - Anonymous Online Contributor

Unverified Answer

Can horizontal ridge deficiency be cured?

"The procedure is a simple, minimally-invasive, and reproducible method with satisfactory results that is reliable and the most efficient technique for correcting HTRDF. It provides a good aesthetic outcome with satisfactory patient satisfaction." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in guided bone regeneration (gbr) for therapeutic use?

"Advances in gbr procedures are rapidly advancing the field of gbr and are relevant to a large patient population who may be referred for surgical options to restore or reconstruct the mandible." - Anonymous Online Contributor

Unverified Answer

How serious can horizontal ridge deficiency be?

"Although there are many opinions about the most effective treatment for patients with HRD, the current literature does not contain enough information to define acceptable outcomes of treatment. We have established criteria to gauge the severity of HRD-based facial asymmetry in our institution, and our data suggest that the most important determinants are the extent of horizontal asymmetry, the patient's age, and previous surgery at the mandibular ramus." - Anonymous Online Contributor

Unverified Answer

Has guided bone regeneration (gbr) proven to be more effective than a placebo?

"The current study did not demonstrate any significant difference in bone volume between the treated and control lesions for gbr, especially after 6 to 12 months. There were many factors that led to the uncertainty of the findings: a small sample size, a low bone remodel fraction and the inclusion of only high-risk cases." - Anonymous Online Contributor

Unverified Answer

Is guided bone regeneration (gbr) safe for people?

"The current study did not identify any major technical or safety issues associated with the gbr to treat a horizontal ridge atrophy using the distraction osteogenesis method." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of guided bone regeneration (gbr)?

"The main side effect is bone resorption with minimal or no bone formation. The complication rate is high due to the requirement of multiple surgeries, and the patient needs to be informed about the high risks. For surgeons to successfully perform gbr, they need adequate knowledge of the potential problems that accompany gbr surgery." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets horizontal ridge deficiency?

"There is some difference in the mean age of presentation for the horizontal ridge deficiency when compared to the other malocclusions. However, there is a lack of significant difference [between different cohorts] for the mean age of presentation of the horizontal ridge deficiency." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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