Clinical trial NCT05505084: Alveolar Ridge Preservation Following Tooth Extraction.
Official title: Comparison of Five Distinct Membranes for Preservation of the Alveolar Ridge Following Tooth Extraction: A Prospective, Randomized, Controlled Clinical Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Tooth Fractures
Tooth Extraction Status Nos
Caries
Keywords: implant
alveolar ridge preservation
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: ZimVie
First posted: 2022-08-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of subjects presenting to the University of Pennsylvania School of Dental Medicine who require extraction of a hopeless tooth due to trauma, caries, or endodontic/periodontal reasons, and who are interested in replacing their tooth with a dental implant.

Brief 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Ridge dimension changes before and after the augmentation.
timeFrame: from the date of the extraction 4 months
measure: Histological Evaluation
timeFrame: 4 months post-augmentation
Secondary outcomes:
measure: Implant site conditions
timeFrame: 4 months post-augmentation
measure: Implant site conditions
timeFrame: 4 months post-augmentation
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Dental Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Yu-Cheng Chang, DMD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: 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.
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 September/October;32(5):1001-1017. doi: 10.11607/jomi.5263. Epub 2017 Feb 23.
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.
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.
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.