Impacted CaninesNCT04860388
Gingival Thickness of Impacted Maxillary Canines
A study testing closed eruption technique in people with Impacted Canines and Orthodontic Treatment, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Canines, Orthodontic Treatment, Gingival Thickness
- What is being tested?
- closed eruption technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 May 2019to 15 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 27 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Impacted Canines, Orthodontic Treatment, Gingival Thickness
- Being tested
- closed eruption technique
- Keywords
- Impacted Canine, Closed Eruption Technique, Gingival Thickness, Keratinized Gingival Width, Attached Gingival Width
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed eruption techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: closed eruption technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after the completion of orthodontic treatment
Secondary outcomes (6)
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 .
Measured: 6 months after the completion of orthodontic treatment
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.
Measured: 6 months after the completion of orthodontic treatment
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
Measured: 6 months after the completion of orthodontic treatment
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
Measured: 6 months after the completion of orthodontic treatment
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.
Measured: 6 months after the completion of orthodontic treatment
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.
Measured: 6 months after the completion of orthodontic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start29 May 2019
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impacted CaninesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazli Zeynep Alpaslan Yayli, Yuzuncu Yil University
- Investigators
- Nazli Zeynep Alpaslan Yayli, PhD, Principal investigator, Yuzuncu Yil UniversityYesim Kaya, PhD, Study chair, Ankara Yildirim Beyazıt UniversitySaadet Cinarsoy Cigerim, PhD, Study chair, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860388
- Sponsor's protocol ID
- 29.05.2019/10
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29984786
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04860388
- Acronym / sponsor ID
- 29.05.2019/10
- Conditions
- Impacted Canines, Orthodontic Treatment, Gingival Thickness
- Keywords
- Impacted Canine, Closed Eruption Technique, Gingival Thickness, Keratinized Gingival Width, Attached Gingival Width
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 29 May 2019 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unilateral labially impacted maxillary canines | Active comparator | Procedure: closed eruption techniqueDistalization 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. |
| unilateral palatally impacted maxillary canines | Active comparator | Procedure: closed eruption techniqueDistalization 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. |
Who may qualify
- Ages
- 15 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| closed eruption techniqueThe 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. | Procedure or surgery | unilateral labially impacted maxillary canines, unilateral palatally impacted maxillary canines |
Primary outcome
Gingival Thickness measurement (mm)
Time frame: 6 months after the completion of orthodontic treatment
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 secondary outcomes
keratinized gingival width measurement (mm)
Time frame: 6 months after the completion of orthodontic treatment
attached gingival width measurement (mm)
Time frame: 6 months after the completion of orthodontic treatment
plaque index score (0-3)
Time frame: 6 months after the completion of orthodontic treatment
gingival index score (0-3)
Time frame: 6 months after the completion of orthodontic treatment
gingival bleeding index score (percentage)
Time frame: 6 months after the completion of orthodontic treatment
probing depth measurement (mm)
Time frame: 6 months after the completion of orthodontic treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Background: PubMed 29984786Mummolo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazli Zeynep Alpaslan Yayli, PhD principal investigator
Yuzuncu Yil University
Yesim Kaya, PhD study chair
Ankara Yildirim Beyazıt University
Saadet Cinarsoy Cigerim, PhD study chair
Yuzuncu Yil University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing closed eruption technique in people with Impacted Canines and Orthodontic Treatment, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival Thickness measurement (mm) (time frame: 6 months after the completion of orthodontic treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04860388, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.