Evaluation of Geistlich Fibro-Gide ® and Autogenous Connective Tissue Graft Prior to Orthodontic Maxillary Expansion.

NCT05295771 | Withdrawn

• 1 other identifier: Pro00112336
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Teenage children and adults often undergo orthodontic treatment each year to improve their dental esthetics and chewing function. One common problem they present with is having a small maxilla compared to the mandible. The standard of treatment to correct this issue is to expand the maxilla using either a tooth-anchored expander, a bone-anchored expander, or braces. Unfortunately, these treatment options can sometimes result in a loss of gum tissue and supporting structures of the teeth. Certain patients, especially ones that have thin gum tissue, are at a higher risk of this gum tissue loss. Orthodontic treatment for these patients will expand their jaw, causing further pressure on already thin gums. An increasingly common treatment to prevent this is to proactively modify patient's thin tissue surgically prior to their orthodontic treatment so they can withstand the tooth movement. The gold standard of doing this surgical intervention consists of harvesting a connective tissue from the palate which is not well tolerated by the younger population. Our study will evaluate the use of a biomaterial substitute instead of harvesting the patient's own tissue to thicken the gingival tissues. Surgical healing, patient satisfaction, pain index, as well as tissue contour post orthodontic treatment will be assessed thoroughly. This study will help us understand: 1) if biomaterials can be a substitute for traditional autogenous gum grafts to help thicken the patient's gum tissue prior to orthodontic treatment, and 2) if they are able to withstand the pressure of orthodontic movement. This will be the first long-term study of this kind.

Conditions

Thin Gingiva; Transverse Maxillary Deficiency; Cross Bite

Outcome Measures

Primary Outcomes (5)

• Keratinized Tissue Thickness

  The thickness of the keratinized gingiva will be measured on the mid buccal of the tooth 1 mm apical to the gingival margin using an endo- reamer at the site of surgical intervention.

  Before orthodontic treatment commences on average 4 weeks after surgery.

• Keratinized Tissue Width

  Measure the width from the free gingival margin to the mucogingival junction at the site of surgical intervention.

  12 weeks after surgery

• Keratinized Tissue Width

  Measure the width from the free gingival margin to the mucogingival junction at the site of surgical intervention.

  24 weeks after surgery

• Gingival margin level in relation to the Cemento Enamel Junction CEJ

  The gingival margin will either be at the CEJ, apical to it or coronal to it at the site of surgical intervention.

  12 weeks after surgery

• Gingival margin level in relation to the Cemento Enamel Junction CEJ

  The gingival margin will either be at the CEJ, apical to it or coronal to it at the site of surgical intervention.

  24 weeks after surgery

Secondary Outcomes (7)

• Duration of Surgery

  Day of surgical intervention

• Visual Analog Score for Pain

  One day after surgery.

• Visual Analog Score for Pain

  2 weeks after surgery.

• Visual Analog Score for Discomfort

  One day after surgery.

• Visual Analog Score for Discomfort

  2 weeks after surgery.

Study Arms (2)

Test arm

EXPERIMENTAL

Geistlich Fibro-Gide ®.

Procedure: Gingival Phenotype Modification

Control

ACTIVE COMPARATOR

Autogenous Connective Tissue Graft.

Procedure: Gingival Phenotype Modification

Interventions

Gingival Phenotype Modification PROCEDURE

Autogenous Connective Tissue Graft is the current gold standard for soft tissue phenotype modification. This is being compared with a substitute material called Geistlich Fibro-Gide ® for soft tissue phenotype modification before orthodontic treatment. Geistlich Fibro-Gide ® is a porcine, porous, resorbable and volume-stable collagen matrix, designed for soft-tissue regeneration. Surgical flap design will be an envelope for both interventions.

Control; Test arm

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• presence of all permanent dentition, presence of unilateral or bilateral cross-bite or transverse maxillary deficiency,
• subjects must have at least one tooth with thin gingival phenotype on maxillary canines, premolars or first molars (mesial root only) on either side;
• teeth should have less than 2 mm of keratinized gingiva to be considered for surgical intervention
• subjects should be systemically health.

You may not qualify if:

• patients with Class V restorations or abfractions that obliterate cementoenamel junction
• patients with active caries or endodontically involved teeth
• immunocompromised patients that can influence wound healing
• patients with parafunctional habits
• patient with any history of smoking
• pregnant or lactating females
• teeth that have greater than Miller grade I mobility.

Sponsors & Collaborators

• University of Alberta: lead
• Geistlich Pharma AG: collaborator

Study Sites (1)

University of Alberta, Kaye Edmonton Clinic

Edmonton, Alberta, T6G 2H5, Canada

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Monica P Gibson, BDS,MS(Perio),PhD,FRCD(C)

  U of Alberta Co-Director,Perio Graduate Prog,Faculty of Medicine & Dentistry-Dentistry Dept

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 30 patients with bilaterally thin gingival phenotype and minimal keratinized tissues will be treated randomly (left or right maxillary site to be randomized) with either Geistlich Fibro- Gide ® (Test arm) on one side and Autogenous Connective Tissue Graft (Control arm) on the contralateral side of the mouth.

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: March 25, 2022
• Study Start: April 1, 2022
• Primary Completion: January 23, 2024
• Study Completion: January 23, 2024
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

CA (1)