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Clinical Trials/NCT04550689
NCT04550689Active, not recruitingNot Applicable

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

UConn Health2 sites in 1 country12 target enrollmentStarted: October 1, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
12
Locations
2
Primary Endpoint
Horizontal and vertical dimensional changes noted on Cone Beam Computed Tomography
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description

The participant, surgeon and assessors of the CBCT will be blinded to the treatment arm. The bone graft will be chosen at random from an envelope with a list generated by Sealed Envelope Ltd

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Males or females ≥ 21 years of age
  • •Able to provide informed consent
  • •Good general oral health (no active periodontal disease, absence of hopeless teeth, absence of active caries, absence of acute infections)
  • •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)
  • •Presence of natural teeth adjacent to the tooth planned for extraction
  • •Absence of acute signs of infection such as pus discharge, fistulous tract and / or abscess in relation to tooth being extracted
  • •Dehiscence type defects of the sockets limited to 2/3rd length of the root

Exclusion Criteria

  • •Systemic conditions
  • •Conditions and circumstances as evaluated by investigator that would prevent completion of study participation
  • •Conditions requiring chronic routine use of antibiotics or steroids
  • •History of leukocyte dysfunction or deficiencies, bleeding disorders, neoplastic disease requiring radiation or chemotherapy, metabolic bone disorder, uncontrolled endocrine disorders, HIV infections
  • •Alcoholism or drug abuse and heavy smokers >10 cigarettes a day
  • •Simultaneous participation in other studies
  • •Pregnancy - Patients pregnant before the start of the study or patients who become pregnant during the course of the study
  • •Local conditions
  • •Untreated periodontitis, caries or presence of hopeless teeth (other than the one planned for extraction)
  • •Multi rooted teeth
  • •Irradiation therapy
  • •Osseous lesions
  • •Missing teeth adjacent to the tooth being extracted
  • •Implant restorations adjacent to the tooth being extracted
  • •Multiple socket walls missing following extraction or buccal dehiscence defect extending to the apex of the root

Outcomes

Primary Outcomes

Horizontal and vertical dimensional changes noted on Cone Beam Computed Tomography

Time Frame: 6 months

Dimensional changes measured from a Cone Beam Computed Tomography immediately post extraction and grafting and 6 months post extraction

Secondary Outcomes

  • Histologic analysis of bone biopsy cores(6 months)
  • Horizontal dimensional changes measured intra-operatively using a Periodontal Probe(6 months)
  • Vertical dimensional changes measured intra-operatively using a periodontal probe and stent(6 months)

Investigators

Sponsor
UConn Health
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sejal Thacker

D.D.S., M.D.Sc., Graduate Program Director

UConn Health

Study Sites (2)

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