Alveolar Ridge Preservation Following Tooth Extraction.

Caries Clinical Trial

Official title:

Comparison of Five Distinct Membranes for Preservation of the Alveolar Ridge Following Tooth Extraction: A Prospective, Randomized, Controlled Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05505084
• Other study ID #: 828879
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Caries
• Tooth Extraction Status Nos
• Tooth Fractures

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