Comparison of Dimensional Changes After Tooth Extractions Between Xenograft and Allograft (PilotXenAllo)

A Pilot RCT Study Comparing Dimensional Alterations After Socket Grafting With Xenograft Versus Allograft

To compare dimensional changes in extraction socket of single rooted teeth, 6 months post extraction, when grafted with xenograft versus allograft.

Study Overview

• Status: Active, not recruiting
• Conditions: Tooth Loss
• Intervention / Treatment: Device: Bone graft

Detailed Description

AIM To compare dimensional changes in extraction socket of single rooted teeth, 6 months post extraction, when grafted with xenograft versus allograft.

PRIMARY OBJECTIVE

Horizontal and vertical dimensional changes of extraction sockets as evaluated in a CBCT scan immediately post extraction and 6 months post extraction when grafted with xenograft versus allograft.

SECONDARY OBJECTIVE

1. Difference in horizontal dimensional changes in xenograft and allograft groups as measured intra-operatively after extraction and at re- entry 6 months post extraction.
2. Difference in vertical dimensional changes in xenograft and allograft groups as measured intra-operatively after extraction and at re- entry 6 months post extraction.
3. Difference in histologic analysis of bone biopsy cores taken in xenograft and allograft groups at 6 months re-entry from osteotomy site.

Difference in newly regenerated supracrestal bone height and volume will be measured directly from the segmented images from MicroCT.

NULL HYPOTHESIS

There is no difference between the two groups for any of the parameters evaluated.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • UConn Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Males or females ≥ 21 years of age
2. Able to provide informed consent
3. Good general oral health (no active periodontal disease, absence of hopeless teeth, absence of active caries, absence of acute infections)
4. Single rooted non molar teeth needing extraction for miscellaneous reasons (since histological analysis is being done, it is essential to harvest bone core biopsies without inclusion of native bone16)
5. Presence of natural teeth adjacent to the tooth planned for extraction
6. Absence of acute signs of infection such as pus discharge, fistulous tract and / or abscess in relation to tooth being extracted
7. Dehiscence type defects of the sockets limited to 2/3rd length of the root

Exclusion Criteria:

Systemic conditions

1. Conditions and circumstances as evaluated by investigator that would prevent completion of study participation
2. Conditions requiring chronic routine use of antibiotics or steroids
3. History of leukocyte dysfunction or deficiencies, bleeding disorders, neoplastic disease requiring radiation or chemotherapy, metabolic bone disorder, uncontrolled endocrine disorders, HIV infections
4. Alcoholism or drug abuse and heavy smokers >10 cigarettes a day
5. Simultaneous participation in other studies
6. Pregnancy - Patients pregnant before the start of the study or patients who become pregnant during the course of the study

Local conditions

1. Untreated periodontitis, caries or presence of hopeless teeth (other than the one planned for extraction)
2. Multi rooted teeth
3. Irradiation therapy
4. Osseous lesions
5. Missing teeth adjacent to the tooth being extracted
6. Implant restorations adjacent to the tooth being extracted
7. Multiple socket walls missing following extraction or buccal dehiscence defect extending to the apex of the root

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Xenograft	Device: Bone graft; Bone grafts produced by Straumann LLC
Active Comparator: Allograft	Device: Bone graft; Bone grafts produced by Straumann LLC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Horizontal and vertical dimensional changes noted on Cone Beam Computed Tomography	Dimensional changes measured from a Cone Beam Computed Tomography immediately post extraction and grafting and 6 months post extraction	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Horizontal dimensional changes measured intra-operatively using a Periodontal Probe	Dimensional changes of the crest measured intra-operatively immediately post extraction and grafting and compared to 6 months post extraction. Measurements will be made using a periodontal probe from the Mid-buccal to the mid-palatal/mid-lingual aspect of the ridge using a surgical stent	6 months
Vertical dimensional changes measured intra-operatively using a periodontal probe and stent	Dimensional changes of the crest measured intra-operatively immediately post extraction and grafting and compared to 6 months post extraction. Vertical measurements will be made using a periodontal probe and a patient specific stent. The probe will help measure changes in height of buccal and palatal / lingual plate at the center of the ridge.	6 months
Histologic analysis of bone biopsy cores	Histologic analysis of the bone biopsy cores taken from the xenograft or allograft grafted extraction sockets	6 months

Collaborators and Investigators

• Sponsor: UConn Health
• Collaborators: Institut Straumann AG
• Investigators: Principal Investigator: Sejal Thacker, D.D.S., UConn Health

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): June 30, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: September 7, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: allograft; bone graft; CBCT; xenograft; implant; alveolar; dental; ridge preservation; socket grafting
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: 20-137-1; 601907 (Other Grant/Funding Number: Straumann LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes