Clinical trial NCT04550689: Comparison of Dimensional Changes After Tooth Extractions Between Xenograft and Allograft
Official title: A Pilot RCT Study Comparing Dimensional Alterations After Socket Grafting With Xenograft Versus Allograft
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tooth Loss
Keywords: dental
socket grafting
bone graft
alveolar
xenograft
allograft
implant
ridge preservation
CBCT
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Institut Straumann AG
First posted: 2020-09-16
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel arm with subjects randomly receiving allograft or xenograft for ridge preservation
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Horizontal and vertical dimensional changes noted on Cone Beam Computed Tomography
timeFrame: 6 months
Secondary outcomes:
measure: Horizontal dimensional changes measured intra-operatively using a Periodontal Probe
timeFrame: 6 months
measure: Vertical dimensional changes measured intra-operatively using a periodontal probe and stent
timeFrame: 6 months
measure: Histologic analysis of bone biopsy cores
timeFrame: 6 months
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UConn Health
state: Connecticut
Study officials:
affiliation: UConn Health
name: Sejal Thacker, D.D.S.
role: PRINCIPAL_INVESTIGATOR
References: