NCT04860388

Brief Summary

This study was conducted to compare the periodontal health of labially and palatally impacted maxillary canines with similar mesio-distal displacement, perpendicular distance, and angulation, and to compare them with the contralateral canines that served as control teeth. Two null hypothesis were tested: (1) there are no differences in attached and keratinized gingival widths and gingival thickness between impacted teeth and controls, and (2) there are no differences in attached and keratinized gingival widths and gingival thickness of labially and palatally impacted canines.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 21, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

1.8 years

First QC Date

April 21, 2021

Last Update Submit

April 21, 2021

Conditions

Keywords

Impacted CanineClosed Eruption TechniqueGingival ThicknessKeratinized Gingival WidthAttached Gingival Width

Outcome Measures

Primary Outcomes (1)

  • Gingival Thickness measurement (mm)

    The gingival thicknesses of the impacted canines and controls measured along the long axis of the midbuccal surfaces of teeth under topical anaesthesia at two points: apical to the free gingival margin and coronal to the mucogingival junction. A 15-mm endodontic spreader was perpendicularly positioned to the long axis of the measurement points and gently inserted into the soft tissue until feeling the resistance of alveolar bone. Then, the endodontic spreader was carefully removed and the penetration depth between the tip of the endodontic spreader and silicon stopper was registered using a digital caliper with 0.01-mm sensivity

    6 months after the completion of orthodontic treatment

Secondary Outcomes (6)

  • keratinized gingival width measurement (mm)

    6 months after the completion of orthodontic treatment

  • attached gingival width measurement (mm)

    6 months after the completion of orthodontic treatment

  • plaque index score (0-3)

    6 months after the completion of orthodontic treatment

  • gingival index score (0-3)

    6 months after the completion of orthodontic treatment

  • gingival bleeding index score (percentage)

    6 months after the completion of orthodontic treatment

  • +1 more secondary outcomes

Study Arms (2)

unilateral labially impacted maxillary canines

ACTIVE COMPARATOR

Distalization of the maxillary molars and/or protrusion of the maxillary and mandibular incisors made for creating sufficient space for impacted maxillary canines. After sufficient space for impacted maxillary permanent canine was obtained combine surgical-orthodontic treatment was performed via closed eruption technique. When the crown of the maxillary impacted canine was fully visible in the mouth, its bracket was inserted, and aligned within the dental arch. Posttreatment plaque index, gingival index, gingival bleeding index, probing depth, keratinized and attached gingival width and gingival thickness measurements of the impacted canines and controls were performed. The periodontal health of labially impacted maxillary canines compared with the contralateral canines that served as control teeth.

Procedure: closed eruption technique

unilateral palatally impacted maxillary canines

ACTIVE COMPARATOR

Distalization of the maxillary molars and/or protrusion of the maxillary and mandibular incisors made for creating sufficient space for impacted maxillary canines. After sufficient space for impacted maxillary permanent canine was obtained combine surgical-orthodontic treatment was performed via closed eruption technique. When the crown of the maxillary impacted canine was fully visible in the mouth, its bracket was inserted, and aligned within the dental arch. Posttreatment plaque index, gingival index, gingival bleeding index, probing depth, keratinized and attached gingival width and gingival thickness measurements of the impacted canines and controls were performed. The periodontal health of palatally impacted maxillary canines compared with the contralateral canines that served as control teeth.

Procedure: closed eruption technique

Interventions

The impacted teeth treated with closed eruption technique firstly. Orthodontic traction started a week later the sutures were removed. When the crown of the maxillary impacted canine was fully visible in the mouth, its bracket was inserted, and aligned within the dental arch using double-arch technique. Posttreatment plaque index, gingival index, gingival bleeding index, probing depth, and keratinized and attached gingival width and gingival thickness measurements of the impacted canines and controls were performed. The measurements compared with the contralateral canines that served as control teeth.

unilateral labially impacted maxillary caninesunilateral palatally impacted maxillary canines

Eligibility Criteria

Age15 Years - 27 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • Subjects who had fixed orthodontic treatment with teeth extraction, missing teeth adjacent to the canine, and significant distortion between the left and right half jaws in the initial panoramic radiographs were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nazli Zeynep Alpaslan Yayli

Van, 65100, Turkey (Türkiye)

Location

Related Publications (1)

  • Mummolo S, Nota A, De Felice ME, Marcattili D, Tecco S, Marzo G. Periodontal status of buccally and palatally impacted maxillary canines after surgical-orthodontic treatment with open technique. J Oral Sci. 2018 Dec 27;60(4):552-556. doi: 10.2334/josnusd.17-0394. Epub 2018 Jul 9.

    PMID: 29984786BACKGROUND

Study Officials

  • Nazli Zeynep Alpaslan Yayli, PhD

    Yuzuncu Yil University

    PRINCIPAL INVESTIGATOR
  • Yesim Kaya, PhD

    Ankara Yildirim Beyazıt University

    STUDY CHAIR
  • Saadet Cinarsoy Cigerim, PhD

    Yuzuncu Yil University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, DDA, Assistant professor

Study Record Dates

First Submitted

April 21, 2021

First Posted

April 27, 2021

Study Start

May 29, 2019

Primary Completion

March 15, 2021

Study Completion

March 15, 2021

Last Updated

April 27, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations