Comparison of Dimensional Changes After Tooth Extractions Between Xenograft and Allograft

NCT04550689 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: 20-137-1601907
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tooth Loss

Keywords

dental; socket grafting; bone graft; alveolar; xenograft; allograft; implant; ridge preservation; CBCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Histologic analysis of bone biopsy cores

  6 months

Study Arms (2)

Xenograft

ACTIVE COMPARATOR

Device: Bone graft

Allograft

ACTIVE COMPARATOR

Device: Bone graft

Interventions

Bone graft DEVICE

Bone grafts produced by Straumann LLC

Allograft; Xenograft

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UConn Health: lead
• Institut Straumann AG: collaborator

Study Sites (1)

UConn Health

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Tooth Loss

Interventions

Bone Transplantation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Sejal Thacker, D.D.S.

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: D.D.S., M.D.Sc., Graduate Program Director

Model Details: Parallel arm with subjects randomly receiving allograft or xenograft for ridge preservation

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 16, 2020
• Study Start: October 1, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)