Tooth LossNCT05890170
Patient-reported Outcome Measures After Implant Placement With Contour Augmentation Procedure
An observational study of Tooth Loss and Bone Graft; Complications, run by University of Bern at 1 site in Switzerland.
Trial summary
Maintaining the general health and well-being of patients is the main goal of dental therapy. However, tooth extraction is indicated when teeth cannot be maintained in a status compatible with health, adequate esthetics, function, and/or for strategic reasons. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss, Bone Graft; Complications, Patient Satisfaction
- What is being tested?
- Patient Reported Outcomes Measures
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Jun 2023to 19 Sep 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients treated at the Department of Oral Surgery and Stomatology at the University of Bern will be potentially be recruited. Patients treated with a dental implant with contour augmentation procedure and required post-operative follow-ups as standard of care (short-term group), or patients that had the intervention done 1 to 5 years ago (mid-term group), or longer than 5 years ago (long-term group) will be invited to participate in this study. Patients who expressed an interest to participate in this study at the clinical/phone screening examination, would be informed of the purpose and timeline of the study. All potential subjects will be required to read, understand, and sign the consent form, which included a thorough explanation of the study design, as well as expected benefits and possible risks of participating in the study without limit of time. No monetary compensation would be provided to the participants in this study.
Who may be able to join
- Subjects who had undergone or will have an implant placement procedure involving bone contour augmentation procedure via Guided Bone Regeneration in the anterior esthetic zone at the University of Bern School of Dental Medicine, Switzerland will be screened and invited for a survey. The inclusion criteria are:
- Previous information on the bone augmentation procedure
- Patients willing to provide an informed consent and attend the study
- Absence of any further surgical procedure involving the area of interest.
Who cannot join
- Patients that would not remember where the surgical procedure was performed
- Unwilling or unable to sign the informed consent.
- Besides them, and taking into consideration that no further interventions are provided in this study, no further exclusion criteria are defined.
- Patients who expressed an interest to participate in this study at the clinical screening examination, would be informed of the purpose and timeline of the study. All potential subjects will be required to read, understand, and sign the consent form, which included a thorough explanation of the study design, as well as expected benefits and possible risks of participating in the study.
- The initial recruitment of patients would be based on their confirmation of recalling the implant placement surgery involving the bone contour augmentation procedure via GBR, its purpose, and the area of the oral cavity where the procedure was performed. In the short-term group the patients would be followed at 1-week, 2-weeks, one and three months after surgery. Mid-term would-be patients that had the procedure performed between one up to 5 years. Long-term group would be patients that had the procedure performed from 5 years up to 20 years.
Trial locations and contacts
1 site in 1 country.
About this study
Maintaining the general health and well-being of patients is the main goal of dental therapy. However, tooth extraction is indicated when teeth cannot be maintained in a status compatible with health, adequate esthetics, function, and/or for strategic reasons. A variable degree of alveolar ridge atrophy related to bone resorption is initiated immediately after removal of a tooth due to the local physiologic remodeling and the inflammatory response. Ridge resorption is more accentuated in the horizontal dimension, followed by the vertical mid-facial and vertical mid-lingual in non-molar and molar teeth. Among local periodontal phenotypic characteristics, facial bone thickness at the time of tooth extraction seems to be strongly associated with the extent of alveolar bone resorption.
Dental implants have increased in popularity due to their unique ability to replace teeth. During the planning phase of implant therapy, one of the main parameters assessed is the amount of residual alveolar ridge. Therefore, when tooth replacement therapy via dental implant is considered, adequate management of the site is critical to predictably preserve or reconstruct the architecture of the alveolar ridge, particularly in the anterior aesthetic zone, where its structure play a crucial role in the maintenance of function, health and esthetics. Generally, with appropriate treatment planning and execution, the adequate primary mechanical stability of the dental implant is achieved. However, bone and/or soft tissue augmentation procedures could be needed for the adequate management of deficient edentulous ridges at the time of implant placement, and these types of treatments could considerably increase the risk of morbidity, treatment expenses, and length of treatment time. Nevertheless, Implant placement with additional bone contour augmentation therapies have shown their effectiveness in the short-, mid- and long-term in contemporary dental practice.
However, to the present date, there is no information available in the literature regarding patient-reported outcome measures in patients that received tooth replacement therapy via dental implants with additional contour bone augmentation in the short-, mid- and long-term.
Read the detailed description
This study is designed as a serial cross-sectional study. Subjects who had undergone an implant placement procedure involving bone contour augmentation procedure via GBR in the anterior aesthetic zone at the University of Bern School of Dental Medicine, Switzerland will be screened and invited for a survey. During the recall exams, patient-reported outcomes will be obtained utilizing standardized questionnaires. These outcome measures will enable us to compile short-, mid-, and long-term data about the patient-reported outcomes measures of tooth replacement therapy with dental implants and additional bone contour augmentation procedure and establish possible correlation with patient (i.e., age, sex, systemic diseases) and surgical-related factors (i.e., location and extension of the procedure, needed for vertical releasing incisions, previous management of the extraction site, etc).
The findings of this study could bring a valuable perspective on the replacement of missing teeth with dental implants and contour augmentation procedures and would provide clinicians and researchers novel knowledge to guide the clinical decision-making process.
Project population, inclusion and exclusion criteria Subjects who had undergone implant placement procedure involving bone contour augmentation procedure via Guided Bone Regeneration in the anterior esthetic zone at the University of Bern School of Dental Medicine, Switzerland will be screened and invited for a survey. The inclusion criteria are: 1) previous information on the bone augmentation procedure; 2) patients willing to provide an informed consent and attend the study, and 3) absence of any further surgical procedure involving the area of interest. The exclusion criteria are: 1) patients that would not remember where the surgical procedure was performed; 2) unwilling or unable to sign the informed consent. Besides them, and taking into consideration that no further interventions are provided in this study, no further exclusion criteria are defined.
Patients who expressed an interest to participate in this study at the clinical screening examination, would be informed of the purpose and timeline of the study. All potential subjects will be required to read, understand, and sign the consent form, which included a thorough explanation of the study design, as well as expected benefits and possible risks of participating in the study.
The initial recruitment of patients would be based on their confirmation of recalling the implant placement surgery involving the bone contour augmentation procedure via GBR, its purpose, and the area of the oral cavity where the procedure was performed. In the short-term group the patients would be followed at 1-week, 2-weeks, one and three months after surgery. Mid-term would-be patients that had the procedure performed between one up to 5 years. Long-term group would be patients that had the procedure performed from 5 years up to 20 years.
Recruitment, screening and informed consent procedure Patients treated at the Department of Oral Surgery and Stomatology at the University of Bern will be potentially be recruited. Patients treated with a dental implant with contour augmentation procedure and required post-operative follow-ups as standard of care (short-term group), or patients that had the intervention done 1 to 5 years ago (mid-term group), or longer than 5 years ago (long-term group) will be invited to participate in this study. Patients who expressed an interest to participate in this study at the clinical/phone screening examination, would be informed of the purpose and timeline of the study. All potential subjects will be required to read, understand, and sign the consent form, which included a thorough explanation of the study design, as well as expected benefits and possible risks of participating in the study without limit of time. No monetary compensation would be provided to the participants in this study.
Study procedures Patients would received questionnaires. Data for the analyses would be extracted only from the questionnaire of patients. Subjects would be asked to mark a 100mm visual analogue scale (VAS) relative to the pain/discomfort that they are/had experienced from the procedure and satisfaction with the procedure. Patients would also been given the option to mark "I do not remember" if they do not recall the answer.
Data from questionnaires would be extracted by an independent investigator. Different variables would be included: 1) age, sex, systemic factors, date of the procedure; 2) location and extension of the procedure; 3) needed for vertical releasing incisions; 4) prescription of additional medication after the 2-week post-op appointment; 5) local anatomical factors (i.e., mid-facial keratinized mucosa width), presence of adjacent teeth; 6) status of post-operative healing; 7) complications during the healing period (i.e., flap dehiscence, necrosis, bone grafting extravasation, pain, infection); 8) operator (resident or faculty member).
The duration of the evaluation visit would take no longer than 10 minutes during the recall appointment. After this visit, in the mid-term and long-term group, no more visits will be necessary for the study outcomes. For the short-term group, during the different follow-up visits as the standard of care after this type of this procedure, the patient would receive similar questionnaires relative to the pain/discomfort and/or satisfaction. Standardized Oral Health Related Questionnaries (OHIP) would be also given to the patients. All the data collected will be encrypted in Redcap Software. The key for the enecryption will be set up and stored by a person who is not involved in the study.
Withdrawal and discontinuation Only patients that would not remember where the surgical procedure was performed or unwilling and unable to sign the informed consent will not be included in this research project. In the short-term group, if the patient during the next follow-up does not want to participate anymore in the study, would not be included in this research project
- Conditions
- Tooth Loss, Bone Graft; Complications, Patient Satisfaction, Patient Acceptance of Health Care
- Being tested
- Patient Reported Outcomes Measures
- Medical subject headings
- Tooth Loss, Patient Satisfaction, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Reported Outcomes MeasuresOther
Questionnaires and information extracted from the medical records would be collected.
| Study group | Role | What they receive |
|---|---|---|
| Short-term | Patients treated at the Department of Oral Surgery and Stomatology at the University of Bern will be potentially be recruited. Patients treated with a dental implant with contour augmentation procedure and required post-operative follow-ups as standard of care (short-term group) will be invited to participate in this study. Patients who expressed an interest to participate in this study at the clinical/phone screening examination, would be informed of the purpose and timeline of the study. All potential subjects will be required to read, understand, and sign the consent form, which included a thorough explanation of the study design, as well as expected benefits and possible risks of participating in the study without limit of time.
Patients would received questionnaires. Data from questionnaires would be extracted by an independent investigator. Different variables would be included: 1) age, sex, systemic factors, date of the procedure; location and extension of the procedure... Receives: Other: Patient Reported Outcomes Measures | |
| Mid-term | Patients treated at the Department of Oral Surgery and Stomatology at the University of Bern will be potentially be recruited. Patients treated with a dental implant with contour augmentation procedure done 1 to 5 years ago (mid-term group) will be invited to participate in this study. Patients who expressed an interest to participate in this study at the clinical/phone screening examination, would be informed of the purpose and timeline of the study. All potential subjects will be required to read, understand, and sign the consent form, which included a thorough explanation of the study design, as well as expected benefits and possible risks of participating in the study without limit of time.
Patients would received questionnaires. Data from questionnaires would be extracted by an independent investigator. Different variables would be included: 1) age, sex, systemic factors, date of the procedure; location and extension of the procedure... Receives: Other: Patient Reported Outcomes Measures | |
| Long-term | Patients treated at the Department of Oral Surgery and Stomatology at the University of Bern will be potentially be recruited. Patients treated with a dental implant with contour augmentation procedure done >5 years ago (mid-term group) will be invited to participate in this study. Patients who expressed an interest to participate in this study at the clinical/phone screening examination, would be informed of the purpose and timeline of the study. All potential subjects will be required to read, understand, and sign the consent form, which included a thorough explanation of the study design, as well as expected benefits and possible risks of participating in the study without limit of time.
Patients would received questionnaires. Data from questionnaires would be extracted by an independent investigator. Different variables would be included: 1) age, sex, systemic factors, date of the procedure; location and extension of the procedure... Receives: Other: Patient Reported Outcomes Measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of willingness of the patients that are undergoing or underwent the placement of implants in the anterior esthetic area with additional bone contour augmentation procedure via GBR.
Primary objective
Measured: Through study completion, an average of 3 months, and one year after the procedure was completed
Secondary outcomes (3)
- To assess whether the presence of time have an influence on the willingness of the patient to perform this type of procedure again.
Secondary objective
Measured: Through study completion, an average of 3 months, and one year after the procedure was completed
- To assess the influence of the other variables on the willingness of the patient to perform this type of procedure, overall patient satisfaction and discomfort.
Secondary objective
Measured: Through study completion, an average of 3 months, and one year after the procedure was completed
- To assess the influence of the other variables on the patient reported outcomes measures after this type of procedure.
Secondary objective
Measured: Through study completion, an average of 3 months, and one year after the procedure was completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start8 Jun 2023
- Primary completion15 Jun 2024
- Study completion19 Sep 2024
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 Tooth LossStudies of the same condition, open and under way.
- More trials run by University of BernThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilio Couso, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890170
- Sponsor's protocol ID
- 2023-00754
- Other IDs
- 2023
- Status last verified
- Jul 2023
- First submitted
- 16 May 2023
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
1. Araujo MG, Lindhe J. 2005. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 32(2):212-218. 2. Avila-Ortiz G, Chambrone L, Vignoletti F. 2019. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 46 Suppl 21:195-223. 3. Avila-Ortiz G, Gonzalez-Martin O, Couso-Queiruga E, Wang HL. 2020. The peri-implant phenotype. J Periodontol. 91(3):283-288. 4. Cardaropoli G, Araujo M, Lindhe J. 2003. Dynamics of bone tissue formation in tooth extraction sites. An experimental study in dogs. J Clin Periodontol. 30(9):809-818. 5. Chapple IL, Wilson NH. 2014. Manifesto for a paradigm shift: Periodontal health for a better life. Br Dent J. 216(4):159-162. 6. Chappuis V, Engel O, Reyes M, Shahim K, Nolte LP, Buser D. 2013. Ridge alterations post-extraction in the esthetic zone: A 3d analysis with cbct. J Dent Res. 92(12 Suppl):195S-201S. 7. Clementini M, Agostinelli A, Castelluzzo W, Cugnata F, Vignoletti F, De Sanctis M. 2019. The effect of immediate implant placement on alveolar ridge preservation compared to spontaneous healing after tooth extraction: Radiographic results of a randomized controlled clinical trial. J Clin Periodontol. 46(7):776-786. 8. Couso-Queiruga E, Stuhr S, Tattan M, Chambrone L, Avila-Ortiz G. 2021. Post-extraction dimensional changes: A systematic review and meta-analysis. J Clin Periodontol. 48(1):126-144. 9. Lim G, Lin GH, Monje A, Chan HL, Wang HL. 2018. Wound healing complications following guided bone regeneration for ridge augmentation: A systematic review and meta-analysis. Int J Oral Maxillofac Implants. 33(1):41-50. 10. Chappuis V, Rahman L, Buser R, Janner SFM, Belser UC, Buser D. Effectiveness of Contour Augmentation with Guided Bone Regeneration: 10-Year Results. J Dent Res. 2018 Mar;97(3):266-274. 11. Buser D, Halbritter S, Hart C, Bornstein MM, Grütter L, Chappuis V, Belser UC. Early implant placement with simultaneous guided bone regeneration following single-tooth extraction in the esthetic zone: 12-month results of a prospective study with 20 consecutive patients. J Periodontol. 2009 Jan;80(1):152-62. 12. Buser D, Wittneben J, Bornstein MM, Grütter L, Chappuis V, Belser UC. Stability of contour augmentation and esthetic outcomes of implant-supported single crowns in the esthetic zone: 3-year results of a prospective study with early implant placement postextraction. J Periodontol. 2011 Mar;82(3):342-9. 13. Ordinance on Human Research with the Exception of Clinical trials (HRO) https://www.admin.ch/opc/en/classified-compilation/20121177/index.html 14. Human Research Act (HRA) http://www.admin.ch/opc/en/classified-compilation/20121176/201401010000/810.305.pdf 15. Declaration of Helsinki (https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects ) 16. STROBE statement (http://www.jclinepi.com/article/S0895-4356(07)00436-2/pdf)
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-reported Outcome Measures After Implant Placement With Contour Augmentation Procedure
- ClinicalTrials.gov ID
- NCT05890170
- Acronym / sponsor ID
- 2023-00754
- Conditions
- Tooth Loss, Bone Graft; Complications, Patient Satisfaction, Patient Acceptance of Health Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 6 Jun 2023 (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.
Maintaining the general health and well-being of patients is the main goal of dental therapy. However, tooth extraction is indicated when teeth cannot be maintained in a status compatible with health, adequate esthetics, function, and/or for strategic reasons. A variable degree of alveolar ridge atrophy related to bone resorption is initiated immediately after removal of a tooth due to the local physiologic remodeling and the inflammatory response. Ridge resorption is more accentuated in the horizontal dimension, followed by the vertical mid-facial and vertical mid-lingual in non-molar and molar teeth. Among local periodontal phenotypic characteristics, facial bone thickness at the time of tooth extraction seems to be strongly associated with the extent of alveolar bone resorption.
Dental implants have increased in popularity due to their unique ability to replace teeth. During the planning phase of implant therapy, one of the main parameters assessed is the amount of residual alveolar ridge. Therefore, when tooth replacement therapy via dental implant is considered, adequate management of the site is critical to predictably preserve or reconstruct the architecture of the alveolar ridge, particularly in the anterior aesthetic zone, where its structure play a crucial role in the maintenance of function, health and esthetics. Generally, with appropriate treatment planning and execution, the adequate primary mechanical stability of the dental implant is achieved. However, bone and/or soft tissue augmentation procedures could be needed for the adequate management of deficient edentulous ridges at the time of implant placement, and these types of treatments could considerably increase the risk of morbidity, treatment expenses, and length of treatment time. Nevertheless, Implant placement with additional bone contour augmentation therapies have shown their effectiveness in the short-, mid- and long-term in contemporary dental practice.
However, to the present date, there is no information available in the literature regarding patient-reported outcome measures in patients that received tooth replacement therapy via dental implants with additional contour bone augmentation in the short-, mid- and long-term.
Detailed description
This study is designed as a serial cross-sectional study. Subjects who had undergone an implant placement procedure involving bone contour augmentation procedure via GBR in the anterior aesthetic zone at the University of Bern School of Dental Medicine, Switzerland will be screened and invited for a survey. During the recall exams, patient-reported outcomes will be obtained utilizing standardized questionnaires. These outcome measures will enable us to compile short-, mid-, and long-term data about the patient-reported outcomes measures of tooth replacement therapy with dental implants and additional bone contour augmentation procedure and establish possible correlation with patient (i.e., age, sex, systemic diseases) and surgical-related factors (i.e., location and extension of the procedure, needed for vertical releasing incisions, previous management of the extraction site, etc).
The findings of this study could bring a valuable perspective on the replacement of missing teeth with dental implants and contour augmentation procedures and would provide clinicians and researchers novel knowledge to guide the clinical decision-making process.
Project population, inclusion and exclusion criteria Subjects who had undergone implant placement procedure involving bone contour augmentation procedure via Guided Bone Regeneration in the anterior esthetic zone at the University of Bern School of Dental Medicine, Switzerland will be screened and invited for a survey. The inclusion criteria are: 1) previous information on the bone augmentation procedure; 2) patients willing to provide an informed consent and attend the study, and 3) absence of any further surgical procedure involving the area of interest. The exclusion criteria are: 1) patients that would not remember where the surgical procedure was performed; 2) unwilling or unable to sign the informed consent. Besides them, and taking into consideration that no further interventions are provided in this study, no further exclusion criteria are defined.
Patients who expressed an interest to participate in this study at the clinical screening examination, would be informed of the purpose and timeline of the study. All potential subjects will be required to read, understand, and sign the consent form, which included a thorough explanation of the study design, as well as expected benefits and possible risks of participating in the study.
The initial recruitment of patients would be based on their confirmation of recalling the implant placement surgery involving the bone contour augmentation procedure via GBR, its purpose, and the area of the oral cavity where the procedure was performed. In the short-term group the patients would be followed at 1-week, 2-weeks, one and three months after surgery. Mid-term would-be patients that had the procedure performed between one up to 5 years. Long-term group would be patients that had the procedure performed from 5 years up to 20 years.
Recruitment, screening and informed consent procedure Patients treated at the Department of Oral Surgery and Stomatology at the University of Bern will be potentially be recruited. Patients treated with a dental implant with contour augmentation procedure and required post-operative follow-ups as standard of care (short-term group), or patients that had the intervention done 1 to 5 years ago (mid-term group), or longer than 5 years ago (long-term group) will be invited to participate in this study. Patients who expressed an interest to participate in this study at the clinical/phone screening examination, would be informed of the purpose and timeline of the study. All potential subjects will be required to read, understand, and sign the consent form, which included a thorough explanation of the study design, as well as expected benefits and possible risks of participating in the study without limit of time. No monetary compensation would be provided to the participants in this study.
Study procedures Patients would received questionnaires. Data for the analyses would be extracted only from the questionnaire of patients. Subjects would be asked to mark a 100mm visual analogue scale (VAS) relative to the pain/discomfort that they are/had experienced from the procedure and satisfaction with the procedure. Patients would also been given the option to mark "I do not remember" if they do not recall the answer.
Data from questionnaires would be extracted by an independent investigator. Different variables would be included: 1) age, sex, systemic factors, date of the procedure; 2) location and extension of the procedure; 3) needed for vertical releasing incisions; 4) prescription of additional medication after the 2-week post-op appointment; 5) local anatomical factors (i.e., mid-facial keratinized mucosa width), presence of adjacent teeth; 6) status of post-operative healing; 7) complications during the healing period (i.e., flap dehiscence, necrosis, bone grafting extravasation, pain, infection); 8) operator (resident or faculty member).
The duration of the evaluation visit would take no longer than 10 minutes during the recall appointment. After this visit, in the mid-term and long-term group, no more visits will be necessary for the study outcomes. For the short-term group, during the different follow-up visits as the standard of care after this type of this procedure, the patient would receive similar questionnaires relative to the pain/discomfort and/or satisfaction. Standardized Oral Health Related Questionnaries (OHIP) would be also given to the patients. All the data collected will be encrypted in Redcap Software. The key for the enecryption will be set up and stored by a person who is not involved in the study.
Withdrawal and discontinuation Only patients that would not remember where the surgical procedure was performed or unwilling and unable to sign the informed consent will not be included in this research project. In the short-term group, if the patient during the next follow-up does not want to participate anymore in the study, would not be included in this research project
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Short-term | – | Other: Patient Reported Outcomes MeasuresPatients treated at the Department of Oral Surgery and Stomatology at the University of Bern will be potentially be recruited. Patients treated with a dental implant with contour augmentation procedure and required post-operative follow-ups as standard of care (short-term group) will be invited to participate in this study. Patients who expressed an interest to participate in this study at the clinical/phone screening examination, would be informed of the purpose and timeline of the study. All potential subjects will be required to read, understand, and sign the consent form, which included a thorough explanation of the study design, as well as expected benefits and possible risks of participating in the study without limit of time. Patients would received questionnaires. Data from questionnaires would be extracted by an independent investigator. Different variables would be included: 1) age, sex, systemic factors, date of the procedure; location and extension of the procedure... |
| Mid-term | – | Other: Patient Reported Outcomes MeasuresPatients treated at the Department of Oral Surgery and Stomatology at the University of Bern will be potentially be recruited. Patients treated with a dental implant with contour augmentation procedure done 1 to 5 years ago (mid-term group) will be invited to participate in this study. Patients who expressed an interest to participate in this study at the clinical/phone screening examination, would be informed of the purpose and timeline of the study. All potential subjects will be required to read, understand, and sign the consent form, which included a thorough explanation of the study design, as well as expected benefits and possible risks of participating in the study without limit of time. Patients would received questionnaires. Data from questionnaires would be extracted by an independent investigator. Different variables would be included: 1) age, sex, systemic factors, date of the procedure; location and extension of the procedure... |
| Long-term | – | Other: Patient Reported Outcomes MeasuresPatients treated at the Department of Oral Surgery and Stomatology at the University of Bern will be potentially be recruited. Patients treated with a dental implant with contour augmentation procedure done >5 years ago (mid-term group) will be invited to participate in this study. Patients who expressed an interest to participate in this study at the clinical/phone screening examination, would be informed of the purpose and timeline of the study. All potential subjects will be required to read, understand, and sign the consent form, which included a thorough explanation of the study design, as well as expected benefits and possible risks of participating in the study without limit of time. Patients would received questionnaires. Data from questionnaires would be extracted by an independent investigator. Different variables would be included: 1) age, sex, systemic factors, date of the procedure; location and extension of the procedure... |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated at the Department of Oral Surgery and Stomatology at the University of Bern will be potentially be recruited. Patients treated with a dental implant with contour augmentation procedure and required post-operative follow-ups as standard of care (short-term group), or patients that had the intervention done 1 to 5 years ago (mid-term group), or longer than 5 years ago (long-term group) will be invited to participate in this study. Patients who expressed an interest to participate in this study at the clinical/phone screening examination, would be informed of the purpose and timeline of the study. All potential subjects will be required to read, understand, and sign the consent form, which included a thorough explanation of the study design, as well as expected benefits and possible risks of participating in the study without limit of time. No monetary compensation would be provided to the participants in this study.
Key inclusion criteria (4 listed)
- Subjects who had undergone or will have an implant placement procedure involving bone contour augmentation procedure via Guided Bone Regeneration in the anterior esthetic zone at the University of Bern School of Dental Medicine, Switzerland will be screened and invited for a survey. The inclusion criteria are:
- Previous information on the bone augmentation procedure
- Patients willing to provide an informed consent and attend the study
- Absence of any further surgical procedure involving the area of interest.
Key exclusion criteria (5 listed)
- Patients that would not remember where the surgical procedure was performed
- Unwilling or unable to sign the informed consent.
- Besides them, and taking into consideration that no further interventions are provided in this study, no further exclusion criteria are defined.
- Patients who expressed an interest to participate in this study at the clinical screening examination, would be informed of the purpose and timeline of the study. All potential subjects will be required to read, understand, and sign the consent form, which included a thorough explanation of the study design, as well as expected benefits and possible risks of participating in the study.
- The initial recruitment of patients would be based on their confirmation of recalling the implant placement surgery involving the bone contour augmentation procedure via GBR, its purpose, and the area of the oral cavity where the procedure was performed. In the short-term group the patients would be followed at 1-week, 2-weeks, one and three months after surgery. Mid-term would-be patients that had the procedure performed between one up to 5 years. Long-term group would be patients that had the procedure performed from 5 years up to 20 years.
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 |
|---|---|---|
| Patient Reported Outcomes MeasuresQuestionnaires and information extracted from the medical records would be collected. | Other | Long-term, Mid-term, Short-term |
Primary outcome
The percentage of willingness of the patients that are undergoing or underwent the placement of implants in the anterior esthetic area with additional bone contour augmentation procedure via GBR.
Time frame: Through study completion, an average of 3 months, and one year after the procedure was completed
Primary objective
3 secondary outcomes
- To assess whether the presence of time have an influence on the willingness of the patient to perform this type of procedure again.
Time frame: Through study completion, an average of 3 months, and one year after the procedure was completed
- To assess the influence of the other variables on the willingness of the patient to perform this type of procedure, overall patient satisfaction and discomfort.
Time frame: Through study completion, an average of 3 months, and one year after the procedure was completed
- To assess the influence of the other variables on the patient reported outcomes measures after this type of procedure.
Time frame: Through study completion, an average of 3 months, and one year after the procedure was completed
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 20 Sep 2024.
- Background1. Araujo MG, Lindhe J. 2005. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 32(2):212-218. 2. Avila-Ortiz G, Chambrone L, Vignoletti F. 2019. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 46 Suppl 21:195-223. 3. Avila-Ortiz G, Gonzalez-Martin O, Couso-Queiruga E, Wang HL. 2020. The peri-implant phenotype. J Periodontol. 91(3):283-288. 4. Cardaropoli G, Araujo M, Lindhe J. 2003. Dynamics of bone tissue formation in tooth extraction sites. An experimental study in dogs. J Clin Periodontol. 30(9):809-818. 5. Chapple IL, Wilson NH. 2014. Manifesto for a paradigm shift: Periodontal health for a better life. Br Dent J. 216(4):159-162. 6. Chappuis V, Engel O, Reyes M, Shahim K, Nolte LP, Buser D. 2013. Ridge alterations post-extraction in the esthetic zone: A 3d analysis with cbct. J Dent Res. 92(12 Suppl):195S-201S. 7. Clementini M, Agostinelli A, Castelluzzo W, Cugnata F, Vignoletti F, De Sanctis M. 2019. The effect of immediate implant placement on alveolar ridge preservation compared to spontaneous healing after tooth extraction: Radiographic results of a randomized controlled clinical trial. J Clin Periodontol. 46(7):776-786. 8. Couso-Queiruga E, Stuhr S, Tattan M, Chambrone L, Avila-Ortiz G. 2021. Post-extraction dimensional changes: A systematic review and meta-analysis. J Clin Periodontol. 48(1):126-144. 9. Lim G, Lin GH, Monje A, Chan HL, Wang HL. 2018. Wound healing complications following guided bone regeneration for ridge augmentation: A systematic review and meta-analysis. Int J Oral Maxillofac Implants. 33(1):41-50. 10. Chappuis V, Rahman L, Buser R, Janner SFM, Belser UC, Buser D. Effectiveness of Contour Augmentation with Guided Bone Regeneration: 10-Year Results. J Dent Res. 2018 Mar;97(3):266-274. 11. Buser D, Halbritter S, Hart C, Bornstein MM, Grütter L, Chappuis V, Belser UC. Early implant placement with simultaneous guided bone regeneration following single-tooth extraction in the esthetic zone: 12-month results of a prospective study with 20 consecutive patients. J Periodontol. 2009 Jan;80(1):152-62. 12. Buser D, Wittneben J, Bornstein MM, Grütter L, Chappuis V, Belser UC. Stability of contour augmentation and esthetic outcomes of implant-supported single crowns in the esthetic zone: 3-year results of a prospective study with early implant placement postextraction. J Periodontol. 2011 Mar;82(3):342-9. 13. Ordinance on Human Research with the Exception of Clinical trials (HRO) https://www.admin.ch/opc/en/classified-compilation/20121177/index.html 14. Human Research Act (HRA) http://www.admin.ch/opc/en/classified-compilation/20121176/201401010000/810.305.pdf 15. Declaration of Helsinki (https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects ) 16. STROBE statement (http://www.jclinepi.com/article/S0895-4356(07)00436-2/pdf)
- 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 Tooth Loss and Bone Graft; Complications, run by University of Bern at 1 site in Switzerland.
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 4 inclusion and 5 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 20 Sep 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 Switzerland. 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?
The percentage of willingness of the patients that are undergoing or underwent the placement of implants in the anterior esthetic area with additional bone contour augmentation procedure via GBR. (time frame: Through study completion, an average of 3 months, and one year after the procedure was completed). 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 NCT05890170, 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 20 Sep 2024.