Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05505084
Other study ID # 828879
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 15, 2022
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source University of Pennsylvania
Contact Yu- Cheng Chang, DMD
Phone 2066173967
Email yuchengc@upenn.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Bone resorption after a tooth extraction is a generally accepted knowledge and has been demonstrated by many animal and human studies. Especially during the first three months followed by the tooth extraction, the volume of bone may change significantly without any interference. Thus, doing a ridge preservation procedure following the extraction is a common standard of care method to maintain the socket volume if implant placement is considered as a treatment option in the future. A variety of materials and methods have been used for ridge preservation. However, it's still inconclusive to determine the best material to maintain the ridge dimension, especially for membrane placement that allows for space maintenance to protect the grafting material. Furthermore, there is no evidence to show any treatment rationale is superior to any other ridge preservation method. In general, the membrane serves the function of the barrier and space protector. The periodontal surgeon use membranes to exclude the epithelium growth and to limit the collapse of the soft tissue into the healing alveolar socket. Regarding resorbable and non-resorbable membrane materials, both serve the function of protecting the graft material from the oral cavity. However, there are also many demonstrating that without membranes the extraction socket healed nicely without any interferences. The question to us is: Do we need the membrane to exclude the epithelium or any kind of surgical dressing material is sufficient enough to preserve the volume of the extracted ridge? The object of this study is to compare five popular membranes on the market that present different characteristics of the membranes.


Description:

The extraction and the grafting procedure involved in this study are standard of care. The investigators will extract the hopeless teeth and prepare the site for implant placement in 4 months. The following products will be used during the study: - Collatape (Zimmer Dental)- approved by the FDA (class III) - Cytoplast (Osteogenics Biomedical)- cleared by the FDA - OssixPlus (Dantum Dental)- cleared by the FDA - Renovix-Plus (Salvin)- cleared by the FDA - BioXclude (SNOASIS)-certificate from the American Association of Tissue Banking - PuroⓇ, Zimmer Dental)- cleared by the FDA - RegenerOssⓇ, Zimmer Dental) - cleared by the FDA During the appointment for the implant placement. A bone core from all subjects in each treatment group will be collected from the augmentation site instead of drilling away. The sample will be evaluated for the following: - % viable of bone - % of connective tissue - % of residual graft material


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Subjects must between the ages of 18 and 80. - Subjects must require removal of at least one maxillary premolar - Subjects should benefit from an implant-supported crown. - Subjects must have voluntarily signed the informed consent form. - Subjects must be assessed as ASA I, ASA II by a member of the research team. Exclusion Criteria: - Medical conditions requiring the use of steroids. - History of leukocyte dysfunction or deficiencies, bleeding deficiencies, renal failure, uncontrolled endocrine disorders, acquired immunodeficiency syndrome or hepatitis. - History of neoplastic disease requiring the use of chemotherapy or irradiation to head and neck. - Subjects who have diabetes mellitus. - Subjects who have undergone administration of any investigational drug or device within 30 days of enrollment in the study. - Alcohol or drug abuse. - Subjects who are heavy smokers (greater than 10 cigarettes per day or cigar equivalents) or chew tobacco. - Conditions or circumstances, in the opinion of the research team, which would prevent completion of study participation or interfere with analysis of study results, such as a history of non-compliance or unreliability.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Tooth extraction and ridge preservation using different barrier mermbranes
The hopeless and unrestorable teeth are planned for extraction and implant placement.

Locations

Country Name City State
United States Penn Dental Medicine Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania ZimVie

Country where clinical trial is conducted

United States, 

References & Publications (10)

Avila-Ortiz G, Elangovan S, Kramer KW, Blanchette D, Dawson DV. Effect of alveolar ridge preservation after tooth extraction: a systematic review and meta-analysis. J Dent Res. 2014 Oct;93(10):950-8. doi: 10.1177/0022034514541127. Epub 2014 Jun 25. — View Citation

Avila-Ortiz G, Gubler M, Romero-Bustillos M, Nicholas CL, Zimmerman MB, Barwacz CA. Efficacy of Alveolar Ridge Preservation: A Randomized Controlled Trial. J Dent Res. 2020 Apr;99(4):402-409. doi: 10.1177/0022034520905660. Epub 2020 Feb 12. — View Citation

Bassir SH, Alhareky M, Wangsrimongkol B, Jia Y, Karimbux N. Systematic Review and Meta-Analysis of Hard Tissue Outcomes of Alveolar Ridge Preservation. Int J Oral Maxillofac Implants. 2018 Sep/Oct;33(5):979-994. doi: 10.11607/jomi.6399. — View Citation

Corbella S, Taschieri S, Francetti L, Weinstein R, Del Fabbro M. Histomorphometric Results After Postextraction Socket Healing with Different Biomaterials: A Systematic Review of the Literature and Meta-Analysis. Int J Oral Maxillofac Implants. 2017 Septe — View Citation

Ismail NM, Mustapha MS, Megat R. The subcellular localisation and the time course of bismuth in the gastric mucosa of rats after short-term administration of colloidal bismuth subcitrate. Ann Acad Med Singap. 1997 Nov;26(6):754-7. — View Citation

Jung RE, Ioannidis A, Hammerle CHF, Thoma DS. Alveolar ridge preservation in the esthetic zone. Periodontol 2000. 2018 Jun;77(1):165-175. doi: 10.1111/prd.12209. Epub 2018 Feb 27. — View Citation

Lekovic V, Kenney EB, Weinlaender M, Han T, Klokkevold P, Nedic M, Orsini M. A bone regenerative approach to alveolar ridge maintenance following tooth extraction. Report of 10 cases. J Periodontol. 1997 Jun;68(6):563-70. doi: 10.1902/jop.1997.68.6.563. — View Citation

Misawa M, Lindhe J, Araujo MG. The alveolar process following single-tooth extraction: a study of maxillary incisor and premolar sites in man. Clin Oral Implants Res. 2016 Jul;27(7):884-9. doi: 10.1111/clr.12710. Epub 2015 Nov 14. — View Citation

Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x. — View Citation

Van der Weijden F, Dell'Acqua F, Slot DE. Alveolar bone dimensional changes of post-extraction sockets in humans: a systematic review. J Clin Periodontol. 2009 Dec;36(12):1048-58. doi: 10.1111/j.1600-051X.2009.01482.x. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Ridge dimension changes before and after the augmentation. The change in alveolar ridge dimensions will be assessed using CBCT technology after extraction and 4 months after extraction. from the date of the extraction 4 months
Primary Histological Evaluation A bone core from all subjects in each treatment group will be taken from the augmentation site at the time of implant placement (4 months post-augmentation) and will be evaluated for the composition of the specimen. 4 months post-augmentation
Secondary Implant site conditions - Implant stability quotients as determined by resonance frequency analysis. 4 months post-augmentation
Secondary Implant site conditions change of the periodontal phenotype 4 months post-augmentation
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05311657 - Oral Health and Severe COPD
Not yet recruiting NCT06438926 - Prevalence of Dental Caries in Patients With Dental Crowding
Completed NCT01529606 - Cold Plasma for Dental Restoration and Caries Prevention N/A
Completed NCT06072742 - Effect of Lifestyle on Caries and Apical Periodontitis
Completed NCT04679558 - Antibacterial Effect of Chlorhexidine Added to the Preventive Protocol in Adolescent Special Needs Early Phase 1
Active, not recruiting NCT04933123 - Clinical Evaluation of a Dental Glass Ceramic in the Indirect Restorative Therapy N/A
Withdrawn NCT02202304 - The Effects of Chlorhexidine/Thymol Varnish on Partial Denture Patient Phase 4
Not yet recruiting NCT04889196 - The Efficiency and Gingival Health Status of Hall Versus SDF Techniques in the Management of Carious Primary Molars Phase 3
Active, not recruiting NCT04708223 - Prospective, Split-mouth, Comparative Study to Compare Clinical Outcomes of Two Different Posterior Composite N/A
Completed NCT06140745 - Evaluation of Dentifrice Formulations to Remineralize Enamel and Dentine Subsurface Lesions in a Double-Blind In-Situ Clinical Trial N/A
Recruiting NCT05144711 - Management of Deep Carious Lesions in Adults N/A
Not yet recruiting NCT03656432 - Effect of CPP-ACP With/Without Fl on White Spot Lesion,Salivary pH and fl Release in High Caries Risk Patients Phase 3
Not yet recruiting NCT02933463 - Clinical Effectiveness of Embrace Wetbond and Clinpro as Pits and Fissure Sealants in Young Permanent Molars N/A
Completed NCT02998814 - Clinical Follow Up of a Fissure Sealant Placed With Different Adhesive Protocols: 2-Year Randomized Split Mouth Study N/A
Completed NCT02027597 - Improving Oral Health With Serious Games N/A
Not yet recruiting NCT05064566 - Evaluation of Caries Detection Methods
Completed NCT06010732 - In Situ Comparison of the Remineralization Potential of Optimized Fluoride Dentifrice With Control Fluoride Dentifrice Phase 3
Recruiting NCT05211843 - Saliva Insulin as Biomarker of Risk Factors for Metabolic Dysregulation and Caries N/A
Not yet recruiting NCT05070416 - Lithium Disilicate Crowns Study N/A
Completed NCT02418520 - The Effect of Miswak Chewing Sticks on the Oral Helicobacter Pylori Infection N/A