Dental ImplantationNCT06491849
Evaluation of Peri-implant Conditions of Orthodontic Mini Implants
An observational study of Dental Implantation and Peri-implant Mucositis, run by Dr. Mehmet Selim Yildiz at 1 site in Turkey (Türkiye).
Trial summary
This observational study aims to evaluate the peri-implant conditions of mini implants placed during orthodontic treatment. Orthodontic mini implants are commonly used as temporary anchorage devices to prevent or reduce unwanted tooth movements during orthodontic treatment. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dental Implantation, Peri-implant Mucositis, Gingival Inflammation
- What is being tested?
- Peri-implant Condition Evaluation
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2021to 20 Sep 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study included patients who had been treated with orthodontic mini implants at the Department of Orthodontics, Faculty of Dentistry, Altinbas University. A total of 16 patients were included in the study.
Who may be able to join
- Participants who have at least one orthodontic mini implant placed for anchorage during orthodontic treatment.
- Systemically healthy individuals.
- Participants without a history of prosthetic treatment.
Who cannot join
- Individuals taking medications that can affect periodontal tissues (e.g., Cyclosporine-A, Calcium Channel Blockers, Phenytoin).
- Individuals with a history of prosthetic treatment.
- Individuals without orthodontic mini implants.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Altinbas University, Faculty of Dentistry
Istanbul, 34147
About this study
Official title: Observational Study on the Peri-implant/Screw Conditions of Mini Implants Placed During Orthodontic Treatment
This observational study aims to evaluate the peri-implant conditions of mini implants placed during orthodontic treatment. Orthodontic mini implants are commonly used as temporary anchorage devices to prevent or reduce unwanted tooth movements during orthodontic treatment. The stability of these implants, both primary and secondary, is crucial for their success. Primary stability refers to the mechanical locking between the implant and bone immediately after placement, while secondary stability is achieved through bone remodeling around the implant over time.
Factors affecting the stability and success of mini implants include the patient's age, gender, cortical bone thickness and density, the site of implant placement, the presence of mobile surrounding tissue, implant dimensions, surface characteristics, and the magnitude and duration of applied orthodontic forces. Peri-implantitis, an inflammation around the implant, is a significant risk factor for implant failure and is influenced by oral hygiene and the quality of surrounding soft tissue.
This study will observe and analyze the peri-implant conditions in patients receiving orthodontic treatment with mini implants, focusing on the incidence of gingival/mucosal inflammation and other factors that may affect implant stability and success.
Read the detailed description
Study Title:
Evaluation of Peri-implant Conditions of Orthodontic Mini Implants
Objective:
The primary objective of this observational study is to evaluate the periodontal conditions surrounding orthodontic mini implants placed during orthodontic treatment. Additionally, the study aims to assess the impact of existing periodontal/peri-implant conditions on the stability of the mini implants.
Background:
Orthodontic mini screws/implants are commonly used as temporary anchorage devices to prevent or reduce unwanted tooth movements during orthodontic treatment. For these mini screws to function effectively as anchorage units, they must be resistant to the forces applied and remain stable at the site of placement throughout their use. Stability is classified into two types: primary stability, which is the mechanical locking between the implant and bone immediately after placement, and secondary stability, which results from bone remodeling around the implant over time. Both types of stability are crucial for the success of mini implants.
Several factors influence the stability and success of mini implants, including the patient's age, gender, cortical bone thickness and density, the site of implant placement, mobility of surrounding tissues, implant dimensions, surface characteristics, and the magnitude and duration of applied orthodontic forces. Peri-implantitis, an inflammation around the implant, is a significant risk factor for implant failure and is influenced by oral hygiene and the quality of surrounding soft tissues.
Hypothesis:
The hypothesis of this study is that the incidence of gingival/mucosal inflammation around the peri-implant/mini screw areas is high.
Methodology:
Patient Population:
The study will include patients treated at Altinbas University Dental Hospital's Departments of Periodontology and Orthodontics between March 2021 and March 2023. Patients must have at least one orthodontic mini implant placed and be systemically healthy. Patients with a history of prosthetic treatment or those taking medications that affect periodontal tissues (e.g., Cyclosporine-A, Calcium Channel Blockers, Phenytoin) will be excluded.
Clinical Assessments:
Primary Assessments:
Clinical periodontal/peri-implant measurements for the entire mouth and each mini implant/screw.
Bleeding on probing (yes/no), suppuration (yes/no), mucosal redness (erythema), plaque index (0-3), gingival index (0-3), probing depth (mm), clinical attachment loss (mm), width of keratinized mucosa (mm), peri-implant mucosal thickness (mm), and radiographic evaluation of the distance between the mini implant/screw and roots (mm).
Secondary Assessments:
Stability of the mini implants/screws measured using a torque gauge. Type of orthodontic force applied, method of placement (with or without a stent), surface characteristics, type (self-tapping/self-drilling), dimensions (diameter and length), duration of application, amount of force applied (<250 grams), and type of orthodontic force system (elastic/coil systems).
Statistical Analysis:
The study will utilize descriptive statistical methods to evaluate the collected data. Due to the original nature of the research, a power analysis could not be performed before the study.
Expected Outcomes:
The findings from this study are expected to highlight the importance of soft tissue health and maintenance during the planning, surgical placement, and post-operative phases of mini implant applications in orthodontics. Additionally, the study aims to elucidate the impact of existing oral hygiene on the stability and force continuity of mini implants in similar patient groups, thereby providing insights into the optimal frequency of periodontal maintenance for individuals with mini implant anchorage.
Study Location:
Altinbas University Dental Hospital, Zuhuratbaba Neighbourhood, Incirli St. No:11-A, 34147 Bakırköy, Istanbul, Turkey.
This detailed description provides a comprehensive overview of your study, outlining its objectives, background, methodology, and expected outcomes in a structured and academic manner.
- Conditions
- Dental Implantation, Peri-implant Mucositis, Gingival Inflammation, Implant Stability, Orthodontics
- Being tested
- Peri-implant Condition Evaluation
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peri-implant Condition EvaluationOther
This intervention involves a detailed clinical evaluation of peri-implant conditions in patients who have received orthodontic mini implants. The assessments include measuring periodontal parameters such as probing depth, bleeding on probing, mucosal redness, plaque index, gingival index, and implant stability. The evaluations are conducted at specified intervals during and after orthodontic anchorage treatment to monitor changes and ensure the health of peri-implant tissues.
| Study group | Role | What they receive |
|---|---|---|
| Orthodontic Mini Implant Group | Participants with at least one orthodontic mini implant placed for anchorage during orthodontic treatment. The study will evaluate the peri-implant conditions, including gingival and mucosal inflammation, implant stability, and other related factors. Receives: Other: Peri-implant Condition Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival/Mucosal Inflammation
Measurement of gingival and mucosal inflammation around the orthodontic mini implants using clinical indices. Units of Measure:
Gingival Index (GI) (0-3) Plaque Index (PI) (0-3)
Measured: 3 months
Probing Pocket/Mucosal Depth
Measurement of the depth of periodontal pockets or mucosal depth around the mini implants. Unit of Measure: Millimeters (mm)
Measured: 3 months
Clinical Attachment Loss (Gingival recession)
Measurement of the loss of attachment or gingival recession in the periodontal tissues and around the mini implants. Unit of Measure: Millimeters (mm)
Measured: 3 months
Width of Keratinized Mucosa
Measurement of the width of keratinized mucosa around the mini implants. Unit of Measure: Millimeters (mm)
Measured: 3 months
Thickness of Peri-Implant/Screw Mucosa
Measurement of the thickness of the mucosa around the mini implants. Unit of Measure: Thick/Thin
Measured: 3 months
Radiographic Evaluation
Measurement of the distance between the mini implant/screw and adjacent roots. Unit of Measure: Millimeters (mm)
Measured: 3 months
Bleeding on Probing
Assessment of the presence or absence of bleeding upon probing around the mini implants and teeth. Unit of Measure: Binary (Yes/No) and given as percentage by the site and full mouth.
Measured: 3 months
Mucosal redness (Erythema)
Assessment of the presence and degree of mucosal redness around the mini implants.
Unit of Measure: Binary (Yes/No)
Measured: 3 months
Mucosal discomfort
Patient-reported discomfort in the area surrounding the mini implants. Unit of Measure: Binary (Yes/No)
Measured: 3 months
Secondary outcomes (1)
Implant Stability
Assessment of the stability of the orthodontic mini implants using a torque gauge to measure insertion and removal torque values. Unit of Measure: Torque (Ncm)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start4 Mar 2021
- Primary completion15 Jun 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Dr. Mehmet Selim Yildiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Mehmet Selim Yildiz, Altinbas University
- Investigators
- Mehmet Selim Yildiz, Asst. Prof., Principal investigator, Altinbas University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491849
- Sponsor's protocol ID
- 2021/49
- Status last verified
- Jul 2024
- First submitted
- 28 Jun 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researchers can request access to the IPD by contacting Dr. Mehmet Selim Yildiz at "mehmet.yildiz2@altinbas.edu.tr"
Publications
Ure DS, Oliver DR, Kim KB, Melo AC, Buschang PH. Stability changes of miniscrew implants over time. Angle Orthod. 2011 Nov;81(6):994-1000. doi: 10.2319/120810-711.1. Epub 2011 May 25.
PubMed 21612317Lee SJ, Ahn SJ, Lee JW, Kim SH, Kim TW. Survival analysis of orthodontic mini-implants. Am J Orthod Dentofacial Orthop. 2010 Feb;137(2):194-9. doi: 10.1016/j.ajodo.2008.03.031.
PubMed 20152674Samrit V, Kharbanda OP, Duggal R, Seith A, Malhotra V. Bone density and miniscrew stability in orthodontic patients. Aust Orthod J. 2012 Nov;28(2):204-12.
PubMed 23304969Zitzmann NU, Berglundh T, Ericsson I, Lindhe J. Spontaneous progression of experimentally induced periimplantitis. J Clin Periodontol. 2004 Oct;31(10):845-9. doi: 10.1111/j.1600-051X.2004.00567.x.
PubMed 15367187Park HS, Jeong SH, Kwon OW. Factors affecting the clinical success of screw implants used as orthodontic anchorage. Am J Orthod Dentofacial Orthop. 2006 Jul;130(1):18-25. doi: 10.1016/j.ajodo.2004.11.032.
PubMed 16849067Parmar R, Reddy V, Reddy SK, Reddy D. Determination of soft tissue thickness at orthodontic miniscrew placement sites using ultrasonography for customizing screw selection. Am J Orthod Dentofacial Orthop. 2016 Oct;150(4):651-658. doi: 10.1016/j.ajodo.2016.03.026.
PubMed 27692423Yildiz MS, Ulutas PA, Ozenci I, Akcali A. Clinical and radiographic assessment of the association between orthodontic mini-screws and periodontal health. BMC Oral Health. 2024 Nov 14;24(1):1376. doi: 10.1186/s12903-024-05136-2.
PubMed 39543578
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Peri-implant/Screw Conditions of Mini Implants Placed During Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT06491849
- Acronym / sponsor ID
- 2021/49
- Conditions
- Dental Implantation, Peri-implant Mucositis, Gingival Inflammation, Implant Stability, Orthodontics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dr. Mehmet Selim YildizUniversity, hospital or other
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 9 Jul 2024 (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 observational study aims to evaluate the peri-implant conditions of mini implants placed during orthodontic treatment. Orthodontic mini implants are commonly used as temporary anchorage devices to prevent or reduce unwanted tooth movements during orthodontic treatment. The stability of these implants, both primary and secondary, is crucial for their success. Primary stability refers to the mechanical locking between the implant and bone immediately after placement, while secondary stability is achieved through bone remodeling around the implant over time.
Factors affecting the stability and success of mini implants include the patient's age, gender, cortical bone thickness and density, the site of implant placement, the presence of mobile surrounding tissue, implant dimensions, surface characteristics, and the magnitude and duration of applied orthodontic forces. Peri-implantitis, an inflammation around the implant, is a significant risk factor for implant failure and is influenced by oral hygiene and the quality of surrounding soft tissue.
This study will observe and analyze the peri-implant conditions in patients receiving orthodontic treatment with mini implants, focusing on the incidence of gingival/mucosal inflammation and other factors that may affect implant stability and success.
Detailed description
Study Title:
Evaluation of Peri-implant Conditions of Orthodontic Mini Implants
Objective:
The primary objective of this observational study is to evaluate the periodontal conditions surrounding orthodontic mini implants placed during orthodontic treatment. Additionally, the study aims to assess the impact of existing periodontal/peri-implant conditions on the stability of the mini implants.
Background:
Orthodontic mini screws/implants are commonly used as temporary anchorage devices to prevent or reduce unwanted tooth movements during orthodontic treatment. For these mini screws to function effectively as anchorage units, they must be resistant to the forces applied and remain stable at the site of placement throughout their use. Stability is classified into two types: primary stability, which is the mechanical locking between the implant and bone immediately after placement, and secondary stability, which results from bone remodeling around the implant over time. Both types of stability are crucial for the success of mini implants.
Several factors influence the stability and success of mini implants, including the patient's age, gender, cortical bone thickness and density, the site of implant placement, mobility of surrounding tissues, implant dimensions, surface characteristics, and the magnitude and duration of applied orthodontic forces. Peri-implantitis, an inflammation around the implant, is a significant risk factor for implant failure and is influenced by oral hygiene and the quality of surrounding soft tissues.
Hypothesis:
The hypothesis of this study is that the incidence of gingival/mucosal inflammation around the peri-implant/mini screw areas is high.
Methodology:
Patient Population:
The study will include patients treated at Altinbas University Dental Hospital's Departments of Periodontology and Orthodontics between March 2021 and March 2023. Patients must have at least one orthodontic mini implant placed and be systemically healthy. Patients with a history of prosthetic treatment or those taking medications that affect periodontal tissues (e.g., Cyclosporine-A, Calcium Channel Blockers, Phenytoin) will be excluded.
Clinical Assessments:
Primary Assessments:
Clinical periodontal/peri-implant measurements for the entire mouth and each mini implant/screw.
Bleeding on probing (yes/no), suppuration (yes/no), mucosal redness (erythema), plaque index (0-3), gingival index (0-3), probing depth (mm), clinical attachment loss (mm), width of keratinized mucosa (mm), peri-implant mucosal thickness (mm), and radiographic evaluation of the distance between the mini implant/screw and roots (mm).
Secondary Assessments:
Stability of the mini implants/screws measured using a torque gauge. Type of orthodontic force applied, method of placement (with or without a stent), surface characteristics, type (self-tapping/self-drilling), dimensions (diameter and length), duration of application, amount of force applied (<250 grams), and type of orthodontic force system (elastic/coil systems).
Statistical Analysis:
The study will utilize descriptive statistical methods to evaluate the collected data. Due to the original nature of the research, a power analysis could not be performed before the study.
Expected Outcomes:
The findings from this study are expected to highlight the importance of soft tissue health and maintenance during the planning, surgical placement, and post-operative phases of mini implant applications in orthodontics. Additionally, the study aims to elucidate the impact of existing oral hygiene on the stability and force continuity of mini implants in similar patient groups, thereby providing insights into the optimal frequency of periodontal maintenance for individuals with mini implant anchorage.
Study Location:
Altinbas University Dental Hospital, Zuhuratbaba Neighbourhood, Incirli St. No:11-A, 34147 Bakırköy, Istanbul, Turkey.
This detailed description provides a comprehensive overview of your study, outlining its objectives, background, methodology, and expected outcomes in a structured and academic manner.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthodontic Mini Implant Group | – | Other: Peri-implant Condition EvaluationParticipants with at least one orthodontic mini implant placed for anchorage during orthodontic treatment. The study will evaluate the peri-implant conditions, including gingival and mucosal inflammation, implant stability, and other related factors. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study included patients who had been treated with orthodontic mini implants at the Department of Orthodontics, Faculty of Dentistry, Altinbas University. A total of 16 patients were included in the study.
Key inclusion criteria (3 listed)
- Participants who have at least one orthodontic mini implant placed for anchorage during orthodontic treatment.
- Systemically healthy individuals.
- Participants without a history of prosthetic treatment.
Key exclusion criteria (3 listed)
- Individuals taking medications that can affect periodontal tissues (e.g., Cyclosporine-A, Calcium Channel Blockers, Phenytoin).
- Individuals with a history of prosthetic treatment.
- Individuals without orthodontic mini implants.
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 |
|---|---|---|
| Peri-implant Condition EvaluationThis intervention involves a detailed clinical evaluation of peri-implant conditions in patients who have received orthodontic mini implants. The assessments include measuring periodontal parameters such as probing depth, bleeding on probing, mucosal redness, plaque index, gingival index, and implant stability. The evaluations are conducted at specified intervals during and after orthodontic anchorage treatment to monitor changes and ensure the health of peri-implant tissues. | Other | Orthodontic Mini Implant Group |
Primary outcome
Gingival/Mucosal Inflammation
Time frame: 3 months
Measurement of gingival and mucosal inflammation around the orthodontic mini implants using clinical indices. Units of Measure: Gingival Index (GI) (0-3) Plaque Index (PI) (0-3)
Probing Pocket/Mucosal Depth
Time frame: 3 months
Measurement of the depth of periodontal pockets or mucosal depth around the mini implants. Unit of Measure: Millimeters (mm)
Clinical Attachment Loss (Gingival recession)
Time frame: 3 months
Measurement of the loss of attachment or gingival recession in the periodontal tissues and around the mini implants. Unit of Measure: Millimeters (mm)
Width of Keratinized Mucosa
Time frame: 3 months
Measurement of the width of keratinized mucosa around the mini implants. Unit of Measure: Millimeters (mm)
Thickness of Peri-Implant/Screw Mucosa
Time frame: 3 months
Measurement of the thickness of the mucosa around the mini implants. Unit of Measure: Thick/Thin
Radiographic Evaluation
Time frame: 3 months
Measurement of the distance between the mini implant/screw and adjacent roots. Unit of Measure: Millimeters (mm)
Bleeding on Probing
Time frame: 3 months
Assessment of the presence or absence of bleeding upon probing around the mini implants and teeth. Unit of Measure: Binary (Yes/No) and given as percentage by the site and full mouth.
Mucosal redness (Erythema)
Time frame: 3 months
Assessment of the presence and degree of mucosal redness around the mini implants. Unit of Measure: Binary (Yes/No)
Mucosal discomfort
Time frame: 3 months
Patient-reported discomfort in the area surrounding the mini implants. Unit of Measure: Binary (Yes/No)
1 secondary outcome
Implant Stability
Time frame: 3 months
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 9 Jul 2024.
- Background: PubMed 21612317Ure DS, Oliver DR, Kim KB, Melo AC, Buschang PH. Stability changes of miniscrew implants over time. Angle Orthod. 2011 Nov;81(6):994-1000. doi: 10.2319/120810-711.1. Epub 2011 May 25.
- Background: PubMed 20152674Lee SJ, Ahn SJ, Lee JW, Kim SH, Kim TW. Survival analysis of orthodontic mini-implants. Am J Orthod Dentofacial Orthop. 2010 Feb;137(2):194-9. doi: 10.1016/j.ajodo.2008.03.031.
- Background: PubMed 23304969Samrit V, Kharbanda OP, Duggal R, Seith A, Malhotra V. Bone density and miniscrew stability in orthodontic patients. Aust Orthod J. 2012 Nov;28(2):204-12.
- Background: PubMed 15367187Zitzmann NU, Berglundh T, Ericsson I, Lindhe J. Spontaneous progression of experimentally induced periimplantitis. J Clin Periodontol. 2004 Oct;31(10):845-9. doi: 10.1111/j.1600-051X.2004.00567.x.
- Background: PubMed 16849067Park HS, Jeong SH, Kwon OW. Factors affecting the clinical success of screw implants used as orthodontic anchorage. Am J Orthod Dentofacial Orthop. 2006 Jul;130(1):18-25. doi: 10.1016/j.ajodo.2004.11.032.
- Background: PubMed 27692423Parmar R, Reddy V, Reddy SK, Reddy D. Determination of soft tissue thickness at orthodontic miniscrew placement sites using ultrasonography for customizing screw selection. Am J Orthod Dentofacial Orthop. 2016 Oct;150(4):651-658. doi: 10.1016/j.ajodo.2016.03.026.
- Derived from this study: PubMed 39543578Yildiz MS, Ulutas PA, Ozenci I, Akcali A. Clinical and radiographic assessment of the association between orthodontic mini-screws and periodontal health. BMC Oral Health. 2024 Nov 14;24(1):1376. doi: 10.1186/s12903-024-05136-2.
- Individual participant dataSharing planned: No. Researchers can request access to the IPD by contacting Dr. Mehmet Selim Yildiz at "mehmet.yildiz2@altinbas.edu.tr"
Related trials for Dental Implantation
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
RecruitingObservational study
Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants
Dental Implants
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
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.
Mehmet Selim Yildiz, Asst. Prof. principal investigator
Altinbas University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implantation and Peri-implant Mucositis, run by Dr. Mehmet Selim Yildiz 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 3 inclusion and 3 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 9 Jul 2024. 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/Mucosal Inflammation (time frame: 3 months). The study lists 9 primary outcomes in all. 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 NCT06491849, which also lists 7 linked publications.
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 9 Jul 2024.