Comparison of Dimensional Changes After Tooth Extractions Between Xenograft and Allograft

Tooth Loss Clinical Trial

— PilotXenAllo  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04550689
• Other study ID #: 20-137-1
• Secondary ID: 601907
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tooth Loss

Intervention

Device:
• Bone graft
Bone grafts produced by Straumann LLC

Locations

Country	Name	City	State
United States	UConn Health	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	Institut Straumann AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Histologic analysis of bone biopsy cores	Histologic analysis of the bone biopsy cores taken from the xenograft or allograft grafted extraction sockets	6 months