Comparison of Dimensional Changes After Tooth Extractions Between Xenograft and Allograft

Not Applicable

Active, not recruiting

• Conditions: Tooth Loss
• Interventions: Device: Bone graft

• Registration Number: NCT04550689
• Lead Sponsor: UConn Health

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-09-07
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-16
• Study Start: 2020-10-01
• Primary Completion: 2023-06-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allograft	Bone graft	-
Xenograft	Bone graft	-

Primary Outcome Measures

Name	Time	Method
Horizontal and vertical dimensional changes noted on Cone Beam Computed Tomography	6 months	Dimensional changes measured from a Cone Beam Computed Tomography immediately post extraction and grafting and 6 months post extraction

Secondary Outcome Measures

Name	Time	Method
Histologic analysis of bone biopsy cores	6 months	Histologic analysis of the bone biopsy cores taken from the xenograft or allograft grafted extraction sockets
Horizontal dimensional changes measured intra-operatively using a Periodontal Probe	6 months	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
Vertical dimensional changes measured intra-operatively using a periodontal probe and stent	6 months	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.

Trial Locations

Locations (1)

UConn Health; 🇺🇸 Farmington, Connecticut, United States