Patient-reported Outcome Measures After Implant Placement With Contour Augmentation Procedure

NCT05890170 | Completed DMC

• 1 other identifier: 2023-00754
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Tooth Loss; Bone Graft; Complications; Patient Satisfaction; Patient Acceptance of Health Care

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  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.

  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.

  Through study completion, an average of 3 months, and one year after the procedure was completed

Study Arms (3)

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...

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...

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...

Other: Patient Reported Outcomes Measures

Interventions

Patient Reported Outcomes Measures OTHER

Questionnaires and information extracted from the medical records would be collected.

Long-term; Mid-term; Short-term

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients that would not remember where the surgical procedure was performed
• Unwilling or unable to sign the informed consent.
• 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.

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

Department of Oral Surgery and Stomatology

Bern, 3010, Switzerland

Location

Related Publications (1)

• 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)

  BACKGROUND

MeSH Terms

Conditions

Tooth Loss; Patient Satisfaction; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, and principal investigator

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 6, 2023
• Study Start: June 8, 2023
• Primary Completion: June 15, 2024
• Study Completion: September 19, 2024
• Last Updated: September 20, 2024

Record last verified: 2023-07

Locations

CH (1)