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OpenTrials
Active, Not Recruiting

NCT Number: NCT04550689

Comparison of Dimensional Changes After Tooth Extractions Between Xenograft and Allograft

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UConn Health

Farmington, Connecticut, 06030, United States

About this study

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

  • Difference in horizontal dimensional changes in xenograft and allograft groups as measured intra-operatively after extraction and at re- entry 6 months post extraction.
  • Difference in vertical dimensional changes in xenograft and allograft groups as measured intra-operatively after extraction and at re- entry 6 months post extraction.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone graft

Device

Bone grafts produced by Straumann LLC

Primary outcomes

  1. 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

  1. Horizontal dimensional changes measured intra-operatively using a Periodontal Probe

    Time frame: 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

  2. Vertical dimensional changes measured intra-operatively using a periodontal probe and stent

    Time frame: 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.

  3. Histologic analysis of bone biopsy cores

    Time frame: 6 months

    Histologic analysis of the bone biopsy cores taken from the xenograft or allograft grafted extraction sockets

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • Institut Straumann AG

Registry information

Official study title

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

Acronym: PilotXenAllo

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Sep 16, 2020
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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