Alveolar Bone LossNCT05659069
Influence of Mandibular Nerve Lateralization on Nutrition and Speech
An observational study of Alveolar Bone Loss and Bone Deformity, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effects of lip numbness on the nutritional status and speech of patients who underwent inferior nerve lateralization for dental implant placement in the mandibular posterior region. For this purpose, observational follow-up of two groups of patients will be performed. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alveolar Bone Loss, Bone Deformity
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 1 Jul 2024
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients with missing teeth in the posterior mandibular region and planned dental implant construction will constitute the study population.
Who may be able to join
- A standard dental implant with or without lateralization of the inferior alveolar nerve in the posterior region of the mandible at the Marmara University Faculty of Dentistry, Department of Oral, Dental and Maxillofacial Surgery clinic.
- The patient accepted to participate in the study and gave written/verbal consent
Who cannot join
- Dental implant placement in the posterior region of the mandible with additional surgical methods (onlay/inlay graft, directed tissue regeneration, etc.) other than nerve lateralization.
- Patients had a neurosensory disorder in the maxillofacial region before implant surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Dentistry
Istanbul, 34854
About this study
Official title: The Effect of Inferior Alveolar Nerve Lateralization on Nutritional Status, Masticatory Performance and Speech; Observational Study
This study aimed to evaluate the effects of lip numbness on the nutritional status and speech of patients who underwent inferior nerve lateralization for dental implant placement in the mandibular posterior region. For this purpose, observational follow-up of two groups of patients will be performed. The control group will include patients with standard implant placement in the mandibular posterior region. The test group will consist of patients with implant placement in the mandibular posterior region with inferior alveolar nerve lateralization. The patients will be evaluated before implant surgery and followed up for four months until the final prosthesis is placed. Changes in nutritional status, masticatory performance and speech abilities will be assessed during this process.
- Conditions
- Alveolar Bone Loss, Bone Deformity
- Keywords
- Dental implants, Mandibular nerve, Nutritional status
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group | 10 patients with dental implant placement without inferior alveolar nerve lateralization | |
| Lateralization group | 10 patients with dental implant placement with inferior alveolar nerve lateralization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in a neurosensory disturbance with a two-point discrimination test
Using a calliper, this test will be carried out. Care should be given to ensure that both calliper tips are touching the lower lip simultaneously until the patient can distinguish between two points of contact, at which point the distance between the two points is noted.
Measured: Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.
Change from baseline in lip sensitivity pattern with semmes-weinstein monofilament test
Mapping of the Semmes-Weinstein monofilament pressure thresholds in the lower lip's predetermined regions.
Measured: Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.
Change from baseline in nutritional status
The Subjective Global Assessment (SGA) will be used to assess changes in nutritional status. SGA is an easy-to-apply, a low-cost and reliable method frequently used to evaluate malnutrition status. After the patient is assessed according to specific criteria, the level of malnutrition is determined by the evaluator's subjective point of view. It is a four-part evaluation. These are weight loss and food intake history, gastrointestinal system symptoms, functional capacity, metabolic requirements, and physical examination. The analysis of the information and the results from it are scored as A, B, C. If the patient is well-nourished, he is classified as A, moderately malnourished, B, and severely malnourished, C. SGA will be applied by the researchers in face-to-face meetings.
Measured: Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.
Change in acoustic characteristics of speech
PRAAT software will be used for scientific analysis of speech and phonetics. In our study, the acoustic properties of speech will be recorded and compared with the help of PRAAT before and after the implant, and it will be examined whether these properties have changed or not. Pitch characteristics, jitter values, shimmer values, intensities and speech breaks, if any, will be observed.
Shimmer (dB): Shimmer is a parameter that shows the relative change between the sound wave amplitudes at short intervals. The peak amplitude of each period is compared with the peak amplitude of the next period, and shimmer can be calculated in dB.
Jitter: Jitter is the parameter that shows the variability of the vibratory cycle frequency with respect to the subsequent cycle frequency.
Measured: Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.
Secondary outcomes (5)
Change from baseline in the masticatory performance
The masticatory performance of patients at the baseline, one month and six months later will be taken with a colour-changeable gum called "XYLITOL" (70x20x1 mm 3 g; Masticatory Performance Evaluating Gum XYLITOL, Lotte, Tokyo, Japan). Colour-changeable gum was first developed to evaluate a person's masticatory performance, changing colour as it is chewed. The gum will be chewed 60 times by the TMD patients. These values will be recorded and compared with the baseline, 1, 2, 3, and 4 months. After chewing, the gum colour will be evaluated according to the improved colour scale. The Colour scale ranges from 1-10, and the masticatory performance will be assessed as poor (1-6), average (7-8), or reasonable (9-10) with the improved colour scale.
Measured: Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.
Change from baseline in body weight
Body weight will be evaluated during face-to-face interviews with patients in baseline, 1, 2, 3, and 4 months with the Tanita DC-360 body analyser. Patients will be asked to remove all metal items (rings, earrings, bracelets, watches, phones, etc.) and any heavy clothing, shoes, or socks before stepping on the device. The device was set to -1.0 kg for the remaining clothes.
Measured: Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.
Change from baseline in food consumption
To evaluate the food consumption of the patients included in the study, at the baseline, 1, 2, 3, and 4 months will be taken with the 24-hour recall method. The amount of nutrients included in the meals will be calculated by using the "Standard Recipes" book, and the measurement amounts will be calculated by using the "Food Photo Catalogue" book. The data obtained from the 24-hour recall method will be analyzed using the "Computer Assisted Nutrition Program, Nutrition Information Systems Package Program (BEBIS)", and the amount of energy, carbohydrates, protein, fat, fiber and micronutrients consumed by participants will be calculated. Intake of energy, macronutrients, fiber and micronutrients will be compared with baseline evaluation followed by reevaluations.
Measured: Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.
Change from baseline in depression test
Beck Depression Scale will be used for the evaluation of depression status. The scale consists of 21 items. Two items are divided into emotions, eleven into cognitions, two into behaviours, five into physical symptoms, and one into interpersonal symptoms. Patients will be asked to choose the most appropriate question for their situation. Each question will be scored as 0, 1, 2, or 3, and scores ranging from 0-63 will be obtained. The results will be evaluated as 0-9 none/minimal depression, 10-18 mild depression, 19-29 moderate depression, and 30-63 severe depression.
Measured: Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.
Change from baseline in observational assessment of chewing
Fried pieces of meat, fried chicken, peeled apples, raw carrots, almonds, hazelnuts, slices of chocolate, bread, pasta, rice, feta cheese, meatballs, boiled carrots, and boiled vegetables prepared with the same standard procedures for each patient will be presented to the patients, and their chewing will be video recorded. It will be taken. Three different researchers evaluated the video recordings; They will be categorised as (I) hard to chew, (II) slightly hard to chew, and (III) easy to chew.
Measured: Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Feb 2023
- Primary completion1 Feb 2024
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferit Bayram, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659069
- Sponsor's protocol ID
- MU_DHF_SBF_05
- Status last verified
- Mar 2024
- First submitted
- 11 Dec 2022
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Krekmanov L, Kahn M, Rangert B, Lindstrom H. Tilting of posterior mandibular and maxillary implants for improved prosthesis support. Int J Oral Maxillofac Implants. 2000 May-Jun;15(3):405-14.
PubMed 10874806de Vicente JC, Pena I, Brana P, Hernandez-Vallejo G. The use of piezoelectric surgery to lateralize the inferior alveolar nerve with simultaneous implant placement and immediate buccal cortical bone repositioning: a prospective clinical study. Int J Oral Maxillofac Surg. 2016 Jul;45(7):851-7. doi: 10.1016/j.ijom.2016.01.017. Epub 2016 Feb 17.
PubMed 26897328Abayev B, Juodzbalys G. Inferior alveolar nerve lateralization and transposition for dental implant placement. Part I: a systematic review of surgical techniques. J Oral Maxillofac Res. 2015 Mar 30;6(1):e2. doi: 10.5037/jomr.2014.6102. eCollection 2015 Jan-Mar.
PubMed 25937873Alling CC. Lateral repositioning of inferior alveolar neurovascular bundle. J Oral Surg. 1977 May;35(5):419. No abstract available.
PubMed 265383Deryabin G, Grybauskas S. Dental implant placement with inferior alveolar nerve repositioning in severely resorbed mandibles: a retrospective multicenter study of implant success and survival rates, and lower lip sensory disturbances. Int J Implant Dent. 2021 Jun 9;7(1):44. doi: 10.1186/s40729-021-00334-x.
PubMed 34105021Khojasteh A, Hassani A, Motamedian SR, Saadat S, Alikhasi M. Cortical Bone Augmentation Versus Nerve Lateralization for Treatment of Atrophic Posterior Mandible: A Retrospective Study and Review of Literature. Clin Implant Dent Relat Res. 2016 Apr;18(2):342-59. doi: 10.1111/cid.12317. Epub 2015 Jun 17.
PubMed 26082191Vetromilla BM, Moura LB, Sonego CL, Torriani MA, Chagas OL Jr. Complications associated with inferior alveolar nerve repositioning for dental implant placement: a systematic review. Int J Oral Maxillofac Surg. 2014 Nov;43(11):1360-6. doi: 10.1016/j.ijom.2014.07.010. Epub 2014 Aug 12.
PubMed 25128261Palacio Garcia-Ochoa A, Perez-Gonzalez F, Negrillo Moreno A, Sanchez-Labrador L, Cortes-Breton Brinkmann J, Martinez-Gonzalez JM, Lopez-Quiles Martinez J. Complications associated with inferior alveolar nerve reposition technique for simultaneous implant-based rehabilitation of atrophic mandibles. A systematic literature review. J Stomatol Oral Maxillofac Surg. 2020 Sep;121(4):390-396. doi: 10.1016/j.jormas.2019.12.010. Epub 2020 Jan 2.
PubMed 31904530Kan JY, Lozada JL, Goodacre CJ, Davis WH, Hanisch O. Endosseous implant placement in conjunction with inferior alveolar nerve transposition: an evaluation of neurosensory disturbance. Int J Oral Maxillofac Implants. 1997 Jul-Aug;12(4):463-71.
PubMed 9274075Hirsch JM, Branemark PI. Fixture stability and nerve function after transposition and lateralization of the inferior alveolar nerve and fixture installation. Br J Oral Maxillofac Surg. 1995 Oct;33(5):276-81. doi: 10.1016/0266-4356(95)90037-3.
PubMed 8555142Lin CS, Wu SY, Huang HY, Lai YL. Systematic Review and Meta-Analysis on Incidence of Altered Sensation of Mandibular Implant Surgery. PLoS One. 2016 Apr 21;11(4):e0154082. doi: 10.1371/journal.pone.0154082. eCollection 2016.
PubMed 27100832Abayev B, Juodzbalys G. Inferior Alveolar Nerve Lateralization and Transposition for Dental Implant Placement. Part II: a Systematic Review of Neurosensory Complications. J Oral Maxillofac Res. 2015 Mar 30;6(1):e3. doi: 10.5037/jomr.2014.6103. eCollection 2015 Jan-Mar.
PubMed 25937874Tomazi MA, da Silveira Gerzson A, Neto AM, da Costa ALP. In-Block Lateralization as a New Technique for Mobilization of the Inferior Alveolar Nerve: A Technique Case Series. J Oral Implantol. 2021 Aug 1;47(4):333-341. doi: 10.1563/aaid-joi-D-20-00041.
PubMed 32838423Fernandez Diaz JO, Naval Gias L. Rehabilitation of edentulous posterior atrophic mandible: inferior alveolar nerve lateralization by piezotome and immediate implant placement. Int J Oral Maxillofac Surg. 2013 Apr;42(4):521-6. doi: 10.1016/j.ijom.2012.10.015. Epub 2012 Nov 12.
PubMed 23153786Hassani A, Saadat S, Moshiri R, Shahmirzad S, Hassani A. Nerve Retraction During Inferior Alveolar Nerve Repositioning Procedure: A New Simple Method and Review of the Literature. J Oral Implantol. 2015 Jul;41 Spec No:391-4. doi: 10.1563/AAID-JOI-D-13-00108. Epub 2013 Dec 17.
PubMed 24344674
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inferior Alveolar Nerve Lateralization on Nutritional Status, Masticatory Performance and Speech; Observational Study
- ClinicalTrials.gov ID
- NCT05659069
- Acronym / sponsor ID
- MU_DHF_SBF_05
- Conditions
- Alveolar Bone Loss, Bone Deformity
- Keywords
- Dental implants, Mandibular nerve, Nutritional status
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 21 Dec 2022 (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 aimed to evaluate the effects of lip numbness on the nutritional status and speech of patients who underwent inferior nerve lateralization for dental implant placement in the mandibular posterior region. For this purpose, observational follow-up of two groups of patients will be performed. The control group will include patients with standard implant placement in the mandibular posterior region. The test group will consist of patients with implant placement in the mandibular posterior region with inferior alveolar nerve lateralization. The patients will be evaluated before implant surgery and followed up for four months until the final prosthesis is placed. Changes in nutritional status, masticatory performance and speech abilities will be assessed during this process.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –10 patients with dental implant placement without inferior alveolar nerve lateralization |
| Lateralization group | – | –10 patients with dental implant placement with inferior alveolar nerve lateralization. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with missing teeth in the posterior mandibular region and planned dental implant construction will constitute the study population.
Key inclusion criteria (2 listed)
- A standard dental implant with or without lateralization of the inferior alveolar nerve in the posterior region of the mandible at the Marmara University Faculty of Dentistry, Department of Oral, Dental and Maxillofacial Surgery clinic.
- The patient accepted to participate in the study and gave written/verbal consent
Key exclusion criteria (2 listed)
- Dental implant placement in the posterior region of the mandible with additional surgical methods (onlay/inlay graft, directed tissue regeneration, etc.) other than nerve lateralization.
- Patients had a neurosensory disorder in the maxillofacial region before implant surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline in a neurosensory disturbance with a two-point discrimination test
Time frame: Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.
Using a calliper, this test will be carried out. Care should be given to ensure that both calliper tips are touching the lower lip simultaneously until the patient can distinguish between two points of contact, at which point the distance between the two points is noted.
Change from baseline in lip sensitivity pattern with semmes-weinstein monofilament test
Time frame: Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.
Mapping of the Semmes-Weinstein monofilament pressure thresholds in the lower lip's predetermined regions.
Change from baseline in nutritional status
Time frame: Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.
The Subjective Global Assessment (SGA) will be used to assess changes in nutritional status. SGA is an easy-to-apply, a low-cost and reliable method frequently used to evaluate malnutrition status. After the patient is assessed according to specific criteria, the level of malnutrition is determined by the evaluator's subjective point of view. It is a four-part evaluation. These are weight loss and food intake history, gastrointestinal system symptoms, functional capacity, metabolic requirements, and physical examination. The analysis of the information and the results from it are scored as A, B, C. If the patient is well-nourished, he is classified as A, moderately malnourished, B, and severely malnourished, C. SGA will be applied by the researchers in face-to-face meetings.
Change in acoustic characteristics of speech
Time frame: Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.
PRAAT software will be used for scientific analysis of speech and phonetics. In our study, the acoustic properties of speech will be recorded and compared with the help of PRAAT before and after the implant, and it will be examined whether these properties have changed or not. Pitch characteristics, jitter values, shimmer values, intensities and speech breaks, if any, will be observed. Shimmer (dB): Shimmer is a parameter that shows the relative change between the sound wave amplitudes at short intervals. The peak amplitude of each period is compared with the peak amplitude of the next period, and shimmer can be calculated in dB. Jitter: Jitter is the parameter that shows the variability of the vibratory cycle frequency with respect to the subsequent cycle frequency.
5 secondary outcomes
Change from baseline in the masticatory performance
Time frame: Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.
Change from baseline in body weight
Time frame: Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.
Change from baseline in food consumption
Time frame: Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.
Change from baseline in depression test
Time frame: Baseline evaluation, followed by reevaluations at 7th days, 2, 3 months.
Change from baseline in observational assessment of chewing
Time frame: Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 10874806Krekmanov L, Kahn M, Rangert B, Lindstrom H. Tilting of posterior mandibular and maxillary implants for improved prosthesis support. Int J Oral Maxillofac Implants. 2000 May-Jun;15(3):405-14.
- Background: PubMed 26897328de Vicente JC, Pena I, Brana P, Hernandez-Vallejo G. The use of piezoelectric surgery to lateralize the inferior alveolar nerve with simultaneous implant placement and immediate buccal cortical bone repositioning: a prospective clinical study. Int J Oral Maxillofac Surg. 2016 Jul;45(7):851-7. doi: 10.1016/j.ijom.2016.01.017. Epub 2016 Feb 17.
- Background: PubMed 25937873Abayev B, Juodzbalys G. Inferior alveolar nerve lateralization and transposition for dental implant placement. Part I: a systematic review of surgical techniques. J Oral Maxillofac Res. 2015 Mar 30;6(1):e2. doi: 10.5037/jomr.2014.6102. eCollection 2015 Jan-Mar.
- Background: PubMed 265383Alling CC. Lateral repositioning of inferior alveolar neurovascular bundle. J Oral Surg. 1977 May;35(5):419. No abstract available.
- Background: PubMed 34105021Deryabin G, Grybauskas S. Dental implant placement with inferior alveolar nerve repositioning in severely resorbed mandibles: a retrospective multicenter study of implant success and survival rates, and lower lip sensory disturbances. Int J Implant Dent. 2021 Jun 9;7(1):44. doi: 10.1186/s40729-021-00334-x.
- Background: PubMed 26082191Khojasteh A, Hassani A, Motamedian SR, Saadat S, Alikhasi M. Cortical Bone Augmentation Versus Nerve Lateralization for Treatment of Atrophic Posterior Mandible: A Retrospective Study and Review of Literature. Clin Implant Dent Relat Res. 2016 Apr;18(2):342-59. doi: 10.1111/cid.12317. Epub 2015 Jun 17.
- Background: PubMed 25128261Vetromilla BM, Moura LB, Sonego CL, Torriani MA, Chagas OL Jr. Complications associated with inferior alveolar nerve repositioning for dental implant placement: a systematic review. Int J Oral Maxillofac Surg. 2014 Nov;43(11):1360-6. doi: 10.1016/j.ijom.2014.07.010. Epub 2014 Aug 12.
- Background: PubMed 31904530Palacio Garcia-Ochoa A, Perez-Gonzalez F, Negrillo Moreno A, Sanchez-Labrador L, Cortes-Breton Brinkmann J, Martinez-Gonzalez JM, Lopez-Quiles Martinez J. Complications associated with inferior alveolar nerve reposition technique for simultaneous implant-based rehabilitation of atrophic mandibles. A systematic literature review. J Stomatol Oral Maxillofac Surg. 2020 Sep;121(4):390-396. doi: 10.1016/j.jormas.2019.12.010. Epub 2020 Jan 2.
- Background: PubMed 9274075Kan JY, Lozada JL, Goodacre CJ, Davis WH, Hanisch O. Endosseous implant placement in conjunction with inferior alveolar nerve transposition: an evaluation of neurosensory disturbance. Int J Oral Maxillofac Implants. 1997 Jul-Aug;12(4):463-71.
- Background: PubMed 8555142Hirsch JM, Branemark PI. Fixture stability and nerve function after transposition and lateralization of the inferior alveolar nerve and fixture installation. Br J Oral Maxillofac Surg. 1995 Oct;33(5):276-81. doi: 10.1016/0266-4356(95)90037-3.
- Background: PubMed 27100832Lin CS, Wu SY, Huang HY, Lai YL. Systematic Review and Meta-Analysis on Incidence of Altered Sensation of Mandibular Implant Surgery. PLoS One. 2016 Apr 21;11(4):e0154082. doi: 10.1371/journal.pone.0154082. eCollection 2016.
- Background: PubMed 25937874Abayev B, Juodzbalys G. Inferior Alveolar Nerve Lateralization and Transposition for Dental Implant Placement. Part II: a Systematic Review of Neurosensory Complications. J Oral Maxillofac Res. 2015 Mar 30;6(1):e3. doi: 10.5037/jomr.2014.6103. eCollection 2015 Jan-Mar.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Alveolar Bone Loss and Bone Deformity, run by Marmara 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Mar 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?
Results are not available in the source record.
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?
Change from baseline in a neurosensory disturbance with a two-point discrimination test (time frame: Baseline function evaluation, followed by reevaluations at 7th days, 2, 3 months.). The study lists 4 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 NCT05659069, which also lists 17 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 12 Mar 2024.