Clinical Trial: Effect of Bone-anchored Protraction on Maxillary Growth in the Young Child

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Effect of Bone-anchored Protraction on Maxillary Growth in the Young Child

Brief Summary: Class III malocclusions may originate in a retrognathic maxilla, a prognathic mandible or both. Young patients with class III malocclusion and maxillary hypoplasia are conventionally treated with a protraction facemask in order to stimulate forward growth of the upper jaw. This treatment option is often inducing unwanted side effects including mesial migration of the teeth in the upper jaw and clockwise rotation of the mandible. Because skeletal effects are often difficult to achieve with this approach, more pronounced class III malocclusions cannot be addressed by face mask therapy. These children cannot be treated during childhood and end up in major orthognathic surgery at full-grown age. To be able to treat also the more pronounced class III malocclusion and to minimize dentoalveolar compensations new treatment methods were developed which uses skeletal anchorage.

Detailed Summary:

Rationale:

Class III malocclusions may originate in a retrognathic maxilla, a prognathic mandible or both. Young patients with class III malocclusion and maxillary hypoplasia are conventionally treated with a protraction facemask or reverse twin block appliance in order to stimulate forward growth of the upper jaw. This treatment option is often inducing unwanted side effects including mesial migration of the teeth in the upper jaw and clockwise rotation of the mandible. Because skeletal effects are often difficult to achieve with this approach, more pronounced class III malocclusions cannot be addressed by face mask therapy. These children cannot be treated during childhood and end up in major orthognathic surgery at full-grown age.

To be able to treat also the more pronounced class III malocclusion and to minimize dentoalveolar compensations new treatment methods were developed which uses skeletal anchorage. In maxillary deficiency cases it's common to have the deficiency anteroposteriorly as well as transversely. Opening of the midpalatal suture by rapid expansion can correct the transverse hypoplasia and may produce more anterior movement of the maxilla. The proposed technique enables to start skeletal anchorage treatment at an earlier age, which also has the potential of more growth modification during treatment.

Objective:

To compare a new technique of skeletal traction with incorporation of maxillary expansion to conventional treatment protocols.

Study design:

This is a RCT

Study population:

Healthy human volunteers (7- 1
Sponsor: Ziekenhuis Oost-Limburg

Current Primary Outcome:

• effect of bone-anchored protraction on maxillary growth in the young child, 1 year with 3D analysis [ Time Frame: 1 year ]
  assessment of anterior growth of the upper jaw, 1 year after start of treatment
• effect of bone-anchored protraction on maxillary growth in the young child, 5 years, with 3D analysis [ Time Frame: 5 years ]
  assessment of anterior growth of the upper jaw, 5 years after start of treatment

Original Primary Outcome:

• effect of bone-anchored protraction on maxillary growth in the young child, 1 year [ Time Frame: 1 year ]
  assessment of anterior growth of the upper jaw, 1 year after start of treatment
• effect of bone-anchored protraction on maxillary growth in the young child, 5 years [ Time Frame: 5 years ]
  assessment of anterior growth of the upper jaw, 5 years after start of treatment

Current Secondary Outcome:

• complications registration [ Time Frame: 1 year ]
  registration of complications due to the use of the new orthodontic bone anchor (mentoplate)
• patient satisfaction [ Time Frame: 1 year ]
  registration of the patient satisfaction, easy to use

Original Secondary Outcome: Same as current

Information By: Ziekenhuis Oost-Limburg

Dates:
Date Received: March 7, 2016
Date Started: April 2016
Date Completion: December 2021
Last Updated: March 16, 2016
Last Verified: March 2016