Posterior Segment Intrusion Using Miniplates

NCT02674191 | Unknown

• 1 other identifier: Jan 2016. Version 1
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Treating hyperdivergent malocclusion accompanied by open bite could be challenging and may be done by several methods as high pull headgear and posterior bite planes or surgically by maxillary impaction in adults. Nowadays it's the skeletal anchorage system (SAS) era as mini-screws and mini-plates ,hence we are aiming for absolute anchorage, and could minimize patient cooperation and the need for surgical treatment.

Conditions

Orthodontic Anchorage Procedures

Keywords

miniplates ,molar intrusion, hyperdivergent

Outcome Measures

Primary Outcomes (1)

• Lower facial height: the distance between soft tissue subnasale and gnathion (Sn.Gn) the difference will be measured in mm. before and after posterior segment intrusion

  This measurement relates principally to the vertical dimensions of the upper dento-alveolar process and the mandible.

  6 months

Study Arms (2)

Group 1

EXPERIMENTAL

Device: mini-plates supported molar intrusion (Stryker, Leibinger, GmbH\& Co., Freiburg, Germany) for molar intrusion using miniplates to treat hyperdivergent adolescence Procedure/Surgery: Application of ULTRACARE benzocaine 20%, topical anesthesia (Ultradent Products, Inc) Procedure/Surgery: Administration of , Mepivacaine-l local anesthesia Procedure/Surgery: BETADINE povidone-iodine 10% a local disinfectant Drug: (150g Clindamycin/tds) for 1 week Postoperative antibiotic Drug: (Cataflam 25mg), are prescribed post-operatively an analgesic

Device: mini-plates supported molar intrusion; Procedure: Application of ULTRACARE benzocaine 20%,; Procedure: Administration of , Mepivacaine-l; Procedure: BETADINE povidone-iodine 10%; Drug: (150g Clindamycin/tds) for 1 week; Drug: (Cataflam 25mg), are prescribed post-operatively

Group 2

NO INTERVENTION

hyperdivergent adolescence with no intervention

Interventions

mini-plates supported molar intrusion DEVICE

(Stryker, Leibinger, GmbH\& Co., Freiburg, Germany) for molar intrusion using miniplates to treat hyperdivergent adolescence

Group 1

Application of ULTRACARE benzocaine 20%, PROCEDURE

topical anesthesia (Ultradent Products, Inc)

Group 1

Administration of , Mepivacaine-l PROCEDURE

local anesthesia

Group 1

BETADINE povidone-iodine 10% PROCEDURE

a local disinfectant

Group 1

(150g Clindamycin/tds) for 1 week DRUG

Postoperative antibiotic

Also known as: Dalacin

Group 1

(Cataflam 25mg), are prescribed post-operatively DRUG

an analgesic

Also known as: NSAIDs

Group 1

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Mild to moderate skeletal Class II
• Super eruption of maxillary posterior segment
• Erupted full set of maxillary permanent teeth except 3rd molar
• Increased lower facial height

You may not qualify if:

• Previous orthodontic treatment
• Any hormonal disorders or syndromes
• Systemic Disease
• Facial Asymmetry
• Para-functional habits

Sponsors & Collaborators

• Manal El Namrawy: lead

Related Publications (5)

• Kuroda S, Sakai Y, Tamamura N, Deguchi T, Takano-Yamamoto T. Treatment of severe anterior open bite with skeletal anchorage in adults: comparison with orthognathic surgery outcomes. Am J Orthod Dentofacial Orthop. 2007 Nov;132(5):599-605. doi: 10.1016/j.ajodo.2005.11.046.

  PMID: 18005833 BACKGROUND

• Ng J, Major PW, Flores-Mir C. True molar intrusion attained during orthodontic treatment: a systematic review. Am J Orthod Dentofacial Orthop. 2006 Dec;130(6):709-14. doi: 10.1016/j.ajodo.2005.05.049.

  PMID: 17169732 BACKGROUND

• Sherwood KH, Burch JG, Thompson WJ. Closing anterior open bites by intruding molars with titanium miniplate anchorage. Am J Orthod Dentofacial Orthop. 2002 Dec;122(6):593-600. doi: 10.1067/mod.2002.128641.

  PMID: 12490869 RESULT

• Greenlee GM, Huang GJ, Chen SS, Chen J, Koepsell T, Hujoel P. Stability of treatment for anterior open-bite malocclusion: a meta-analysis. Am J Orthod Dentofacial Orthop. 2011 Feb;139(2):154-69. doi: 10.1016/j.ajodo.2010.10.019.

  PMID: 21300243 RESULT

• Xun C, Zeng X, Wang X. Microscrew anchorage in skeletal anterior open-bite treatment. Angle Orthod. 2007 Jan;77(1):47-56. doi: 10.2319/010906-14R.1.

  PMID: 17029531 RESULT

MeSH Terms

Interventions

WW Domain-Containing Oxidoreductase; Clindamycin; Diclofenac; Anti-Inflammatory Agents, Non-Steroidal

Intervention Hierarchy (Ancestors)

Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Manal M El Namrawy, MSc.

  assistant lecturer , Beni suef university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 4, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: February 23, 2018

Record last verified: 2018-02