The Effect of Alveolar Ridge Preservation After Tooth Extraction in the Posterior Maxilla

NCT02952209 | Unknown DMC

• 1 other identifier: 16-01597
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to assess the effects of Alveolar Ridge Preservation (ARP) after tooth extraction compared to extraction alone in the posterior maxilla. The results of this study will demonstrate if the use of ARP reduces alveolar ridge resorption at 6 months post extraction in the posterior maxilla region.

Conditions

Tooth Extraction

Keywords

Alveolar Ridge Preservation; Xenograft bone graft; Collagen membrane

Outcome Measures

Primary Outcomes (2)

• Changes in the bucco-palatal width of the alveolar ridge measured in mm.

  Changes in the bucco-palatal width of alveolar ridge from baseline to 6 months, measured using CBCT data.

  6 Months

• Changes in the vertical height of the alveolar ridge measured in mm.

  Changes in the vertical height of the alveolar ridge measured using Cone Beam Computed Tomography (CBCT) data and periapical radiographs.

  6 Months

Secondary Outcomes (8)

• Alveolar bone volumetric changes measured in mm.

  6 Months

• Changes in the distance from the alveolar crestal bone to the sinus floor measured in mm.

  6 months

• Bone density changes from measured in mm.

  6 Months

• Changes in keratinized mucosa width and thickness measured in mm.

  6 months

• Correlation of soft tissue and buccal bone wall thickness measured in mm.

  6 months

Study Arms (2)

No Treatment

NO INTERVENTION

Tooth extraction with no bone graft.

Alveolar Ridge Preservation Treatment

ACTIVE COMPARATOR

Tooth extraction followed by alveolar ridge preservation using xenograft bone graft and covered by a resorbable collagen membrane.

Device: Xenograft

Interventions

Xenograft DEVICE

Alveolar Ridge Preservation Treatment

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must voluntarily sign the informed consent form.
• Subjects must be male or female who are at least 20-70 years of age.
• Subjects must be able and willing to follow study procedures and instructions.
• Presence of one posterior tooth in the right maxilla and one posterior tooth in the left maxilla that require extraction (ADA tooth positions 2-4 and 13-15). The same type of tooth should be in booth side, either two molars or two premolars.
• Teeth extractions of one posterior tooth in the right maxilla and one posterior tooth in the left maxilla must be completed successfully (ADA tooth positions 2-4 and 13-15).
• If present, teeth adjacent to the teeth slated for extraction must be healthy. Healthy teeth are defined as asymptomatic teeth without periapical lesions.

You may not qualify if:

• Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study.
• Subjects who have failed to maintain good plaque control.
• Subjects with any systemic condition such as uncontrolled diabetes mellitus, cancer, HIV, disorders that compromise wound healing, chronic high dose steroid therapy, intravenous and oral bisphosphonate therapy, bone metabolic diseases, history of irradiation of the head and neck area, or any other immuno-suppressive therapy that would contraindicate oral surgical treatment.
• Subjects who report allergy or hypersensitivity to any of the products (collagen membrane and ABBM) used throughout the study.
• Presence of ≥3 mm of vertical loss of the buccal bone in relation to the palatal wall.
• Subjects with untreated periodontitis.
• Presence of acute dentoalveolar infections in the teeth slated for extraction.
• Subjects who are heavy smokers (defined as \>10 cigarettes per day or \>1 cigar per day) or chew tobacco, including within 3 months prior to enrollment.
• Subjects with conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non- compliance or unreliability

Sponsors & Collaborators

• NYU College of Dentistry: lead
• Osteo Science Foundation: collaborator

Study Sites (1)

Bluestone Center for Clinical Research

New York, New York, 10010, United States

Location

Related Publications (12)

• Araujo MG, Liljenberg B, Lindhe J. Dynamics of Bio-Oss Collagen incorporation in fresh extraction wounds: an experimental study in the dog. Clin Oral Implants Res. 2010 Jan;21(1):55-64. doi: 10.1111/j.1600-0501.2009.01854.x.

  PMID: 20070748 BACKGROUND

• Araujo MG, Lindhe J. Socket grafting with the use of autologous bone: an experimental study in the dog. Clin Oral Implants Res. 2011 Jan;22(1):9-13. doi: 10.1111/j.1600-0501.2010.01937.x. Epub 2010 Nov 22.

  PMID: 21091539 BACKGROUND

• Carmagnola D, Adriaens P, Berglundh T. Healing of human extraction sockets filled with Bio-Oss. Clin Oral Implants Res. 2003 Apr;14(2):137-43. doi: 10.1034/j.1600-0501.2003.140201.x.

  PMID: 12656871 BACKGROUND

• Ashman A. Postextraction ridge preservation using a synthetic alloplast. Implant Dent. 2000;9(2):168-76. doi: 10.1097/00008505-200009020-00011.

  PMID: 11307396 BACKGROUND

• Atieh MA, Alsabeeha NH, Payne AG, Duncan W, Faggion CM, Esposito M. Interventions for replacing missing teeth: alveolar ridge preservation techniques for dental implant site development. Cochrane Database Syst Rev. 2015 May 28;2015(5):CD010176. doi: 10.1002/14651858.CD010176.pub2.

  PMID: 26020735 BACKGROUND

• 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.

  PMID: 24966231 BACKGROUND

• Camargo PM, Lekovic V, Weinlaender M, Klokkevold PR, Kenney EB, Dimitrijevic B, Nedic M, Jancovic S, Orsini M. Influence of bioactive glass on changes in alveolar process dimensions after exodontia. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Nov;90(5):581-6. doi: 10.1067/moe.2000.110035.

  PMID: 11077380 BACKGROUND

• Greenstein G, Jaffin RA, Hilsen KL, Berman CL. Repair of anterior gingival deformity with durapatite. A case report. J Periodontol. 1985 Apr;56(4):200-3. doi: 10.1902/jop.1985.56.4.200.

  PMID: 2987474 BACKGROUND

• Norton MR, Wilson J. Dental implants placed in extraction sites implanted with bioactive glass: human histology and clinical outcome. Int J Oral Maxillofac Implants. 2002 Mar-Apr;17(2):249-57.

  PMID: 11958408 BACKGROUND

• Rasperini G, Canullo L, Dellavia C, Pellegrini G, Simion M. Socket grafting in the posterior maxilla reduces the need for sinus augmentation. Int J Periodontics Restorative Dent. 2010 Jun;30(3):265-73.

  PMID: 20386783 BACKGROUND

• Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.

  PMID: 12956475 BACKGROUND

• Soehren SE, Van Swol RL. The healing extraction site: a donor area for periodontal grafting material. J Periodontol. 1979 Mar;50(3):128-33. doi: 10.1902/jop.1979.50.3.128.

  PMID: 285263 BACKGROUND

MeSH Terms

Interventions

Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Ismael E. Khouly, DDS, MS, PhD

  Bluestone Center for Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Periodontology & Implant Dentistry

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 2, 2016
• Study Start: September 27, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)