Effectiveness of SARPE With 3 and 2-Segment Technique: A Randomized Clinical Trial

Maxillary Hypoplasia Clinical Trial

— 3S/2S_SARPE  

Official title:

Effectiveness of Surgically Assisted Rapid Palatal Expansion (SARPE) With 3 and 2-Segment Technique: A Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02179593
• Other study ID #: 464.869
• Status: Active, not recruiting
• Phase: N/A
• First received: June 29, 2014
• Last updated: March 14, 2016
• Start date: September 2013
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Associação Fundo de Incentivo à Pesquisa
• Study type: Interventional

Clinical Trial Summary

A few studies state that 3-segment SARPE has the following advantages: a) higher level of expansion symmetry; b) higher level of stability of the expansion achieved; and c) faster bone healing. The investigators hypothesize that 2-segment SARPE is as effective as 3-segment SARPE concerning treatment and/or quality of life in daily practice.

Description:

32 healthy, literate adult patients (male and female) with 7-millimeter transverse maxilla deficiency bilaterally distributed will participate in this study.

The participants will be assigned randomizable in equal number to undergo either 3-segment or 2-segment SARPE.

Individuals that a) have undergone maxilla surgery previously; b) have craniofacial anomaly;and c) have dental crowding will not be enrolled.

All participants will be assessed before and after surgery for sensitivity to pressure and temperature in the innervated structures linked to the maxilla, as well as for quality of life using OHIP-49 and B-OQLQ assessment tools.

The expansion of maxilla will be assessed by superimposing tomographic images before and after surgery.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 50 Years

Eligibility

Inclusion Criteria:

• Being healthy and literate

• Having 7-millimeter transverse maxilla deficiency bilaterally distributed.

Exclusion Criteria:

• Having undergone maxilla surgery previously

• Having craniofacial anomaly

• Having excessive dental crowding.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Maxillary Hypoplasia

Intervention

Other:
• 2-Segment SARPE
Le Fort I osteotomy with oppening of the median palatal suture and SARPE.
• 3-Segment SARPE
Le Fort I osteotomy with two parallel osteotomies symetrically positioned with reference to the median palatal suture and SARPE.

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life	The primary outcome chosen in this study is Quality of Life assessed through the Orthognathic Quality of Life Questionaire (OQLQ) and Oral Health Impact Profile (OHIP-49) currently available in Portuguese language and validated for scientific studies.	An average of 2 weeks after expansion.	No
Secondary	Maxillary symmetry	The maxillary symmetry will be assessed by analyzing before and after 3D imaging obtained from computed tomography data , superimposed using the Geomagic Qualify software.	pre-operative and an average of 2 weeks at the end of maxillary expansion.	No
Secondary	Stability of dental and osseous structures	The stability of dental and osseous structures will be analyzed using computer-aided 3D analysis of data obtained through the scanning of dental casts using Bicam 3D scanner (Scaierman - Italy).	pre-operative, an average of 2 weeks at the end of the expansion, 4 months, 1 and 2 years after maxillary expansion.	No
Secondary	Nasal and paranasal topographic changes	The nasal and paranasal topographic changes will be captured using laser scanner device.	pre-operative,an average of 2 weeks at the end of the expansion, 4 and 12 months after maxillary expansion.	No