search
Back to results

Gingival Thickness of Impacted Maxillary Canines

Primary Purpose

Impacted Canines, Orthodontic Treatment, Gingival Thickness

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
closed eruption technique
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impacted Canines focused on measuring Impacted Canine, Closed Eruption Technique, Gingival Thickness, Keratinized Gingival Width, Attached Gingival Width

Eligibility Criteria

15 Years - 27 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The inclusion criteria were no previous functional orthopaedic and/or fixed orthodontic treatment, complete permanent dentition, aged between 13 and 20 years old at the begining of the treatment, no systemic problems and related medications, good oral hygiene, no gingival inflammation and periodontal diseases, unilateral labially or palatally impacted maxillary canines, indication of surgical uncovering of the impacted maxillary canine using closed eruption technique, presence of normally positioned contralateral maxillary canine, and complete good quality pretreatment and posttreatment records.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Nazli Zeynep Alpaslan Yayli

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

unilateral labially impacted maxillary canines

unilateral palatally impacted maxillary canines

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

keratinized gingival width measurement (mm)
The keratinized (distance from the gingival margin to the mucogingival junction) gingival width measurements of the impacted canines and controls performed, clinically, parallel to the long axis of teeth at the midbuccal root surfaces .
attached gingival width measurement (mm)
The attached (distance from the gingival groove base to the mucogingival junction) gingival width measurements of the impacted canines and controls performed, clinically, parallel to the long axis of teeth at the midbuccal root surfaces.
plaque index score (0-3)
Plaque index of the impacted canines and controls were measured from the 6 surfaces of each tooth. The plaque index score of each tooth was calculated with Silness-Loe plaque index by dividing the total value by 6. 0: absence of microbial plaque Thin film of microbial plaque along the free gingival margin moderate accumulation with plaque in the sulcus large amount of plaque in sulcus or pocket along the free gingival margin
gingival index score (0-3)
The gingival index of the impacted canines and controls were measured from the 6 surfaces of each tooth. The gingival index score of each tooth was calculated with Silness-Loe gingival indeks by dividing the total value by 6. 0: Normal gingiva Mild inflammation: slight change in color, slight oedema, no bleeding on probing Moderate inflammation: redness, oedema and glazing, bleeding on probing Severe inflammation: marked redness and oedema, ulceration, tendency to spontaneous bleeding
gingival bleeding index score (percentage)
Bleeding on probing scores of the impacted canines and controls were measured by Ainamo and Bay's gingival bleeding index from 6 surfaces of each tooth. If there is bleeding after probing, it is recorded as +, if there is no bleeding it is recorded as _. Gingival bleeding index is calculated as a percentage of affected sites.
probing depth measurement (mm)
Probing depth (PD) (distance from gingival margin to gingival pocket base) of the impacted canines and controls were measured with a probe in 6 regions of each tooth and recorded as mm. measured with a probe in 6 regions of each tooth and recorded as mm.

Full Information

First Posted
April 21, 2021
Last Updated
April 21, 2021
Sponsor
Yuzuncu Yıl University
search

1. Study Identification

Unique Protocol Identification Number
NCT04860388
Brief Title
Gingival Thickness of Impacted Maxillary Canines
Official Title
Comparison of the Gingival Thickness, Keratinized and Attached Gingival Widths of Unilateral Labially and Palatally Impacted Maxillary Canines Erupted by Closed Eruption Technique
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 29, 2019 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
March 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
When a tooth is embedded in the alveolar bone and fails to erupted into the oral cavity within the expected time, dental impaction occurs. Maxillary canine impaction has been observed more frequently in the palatal position than labial position, and unilaterally than bilaterally. Treatment of these teeth, which consitute a transition between the anterior and posterior dental segments and therefore have a great of importance both from functional and aesthetic point of view, is recommended rather than extraction. Many complications that have been reported to be faced during the surgical exposure and orthodontic alignment of the impacted teeth are devitalization, external root resorption, damage to adjacent teeth, marginal bone loss, re-exposure of the tooth, and gingival recession. Gingival recession is the apical migration of the gingival margin beyond the cementoenamel junction, resulting in the clinical exposure of the root surface. The term gingival biotype is generally used to describe the thickness of the gingiva in faciolingual/faciopalatinal direction. Although a large number of existing studies in the broader literature have examined the periodontal health of labially and palatally impacted maxillary canines seperately, limited number of studies compared the labially and palatally maxillary impacted canines. Since one of the factors affecting the posttreatment periodontal health is the initial vertical and horizontal position of the impacted teeth, these studies were observed not provided any information about the pretreatment mesio-distal displacement, perpendicular distance and angulation of the impacted maxillary canines. At this point, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Canines, Orthodontic Treatment, Gingival Thickness
Keywords
Impacted Canine, Closed Eruption Technique, Gingival Thickness, Keratinized Gingival Width, Attached Gingival Width

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
unilateral labially impacted maxillary canines
Arm Type
Active Comparator
Arm Description
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.
Arm Title
unilateral palatally impacted maxillary canines
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
closed eruption technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gingival Thickness measurement (mm)
Description
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
Time Frame
6 months after the completion of orthodontic treatment
Secondary Outcome Measure Information:
Title
keratinized gingival width measurement (mm)
Description
The keratinized (distance from the gingival margin to the mucogingival junction) gingival width measurements of the impacted canines and controls performed, clinically, parallel to the long axis of teeth at the midbuccal root surfaces .
Time Frame
6 months after the completion of orthodontic treatment
Title
attached gingival width measurement (mm)
Description
The attached (distance from the gingival groove base to the mucogingival junction) gingival width measurements of the impacted canines and controls performed, clinically, parallel to the long axis of teeth at the midbuccal root surfaces.
Time Frame
6 months after the completion of orthodontic treatment
Title
plaque index score (0-3)
Description
Plaque index of the impacted canines and controls were measured from the 6 surfaces of each tooth. The plaque index score of each tooth was calculated with Silness-Loe plaque index by dividing the total value by 6. 0: absence of microbial plaque Thin film of microbial plaque along the free gingival margin moderate accumulation with plaque in the sulcus large amount of plaque in sulcus or pocket along the free gingival margin
Time Frame
6 months after the completion of orthodontic treatment
Title
gingival index score (0-3)
Description
The gingival index of the impacted canines and controls were measured from the 6 surfaces of each tooth. The gingival index score of each tooth was calculated with Silness-Loe gingival indeks by dividing the total value by 6. 0: Normal gingiva Mild inflammation: slight change in color, slight oedema, no bleeding on probing Moderate inflammation: redness, oedema and glazing, bleeding on probing Severe inflammation: marked redness and oedema, ulceration, tendency to spontaneous bleeding
Time Frame
6 months after the completion of orthodontic treatment
Title
gingival bleeding index score (percentage)
Description
Bleeding on probing scores of the impacted canines and controls were measured by Ainamo and Bay's gingival bleeding index from 6 surfaces of each tooth. If there is bleeding after probing, it is recorded as +, if there is no bleeding it is recorded as _. Gingival bleeding index is calculated as a percentage of affected sites.
Time Frame
6 months after the completion of orthodontic treatment
Title
probing depth measurement (mm)
Description
Probing depth (PD) (distance from gingival margin to gingival pocket base) of the impacted canines and controls were measured with a probe in 6 regions of each tooth and recorded as mm. measured with a probe in 6 regions of each tooth and recorded as mm.
Time Frame
6 months after the completion of orthodontic treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
27 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The inclusion criteria were no previous functional orthopaedic and/or fixed orthodontic treatment, complete permanent dentition, aged between 13 and 20 years old at the begining of the treatment, no systemic problems and related medications, good oral hygiene, no gingival inflammation and periodontal diseases, unilateral labially or palatally impacted maxillary canines, indication of surgical uncovering of the impacted maxillary canine using closed eruption technique, presence of normally positioned contralateral maxillary canine, and complete good quality pretreatment and posttreatment records. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazli Zeynep Alpaslan Yayli, PhD
Organizational Affiliation
Van Yuzuncu Yil University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yesim Kaya, PhD
Organizational Affiliation
Yildirim Beyazit University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Saadet Cinarsoy Cigerim, PhD
Organizational Affiliation
Van Yuzuncu Yil University
Official's Role
Study Chair
Facility Information:
Facility Name
Nazli Zeynep Alpaslan Yayli
City
Van
ZIP/Postal Code
65100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29984786
Citation
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.
Results Reference
background

Learn more about this trial

Gingival Thickness of Impacted Maxillary Canines

We'll reach out to this number within 24 hrs