Healing Dynamics in Human Extraction Sockets Grafted With Bio-Oss Collagen®

NCT03659617 | Completed Results FDA Device

• 1 other identifier: 201806050
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to clinically, radiographically and histologically evaluate the healing sequence of post-extraction sockets grafted with Bio-Oss Collagen® at 3, 6 and 9 months following tooth extraction in single-rooted tooth sites. Subjects with single rooted teeth planned for extraction and replacement with endosseous dental implants will be recruited for the study based on the eligibility criteria and will be divided in three groups (Groups 1, 2 and 3).A cone-beam computed tomography (CBCT) scan will be obtained and reviewed to prepare for the surgical approach and evaluate the ridge dimensions, the tooth planned for extraction as well as the adjacent sites. After tooth extraction, the socket will be grafted with Bio-Oss Collagen® and, depending on the morphology of the extraction sockets, a collagen matrix (Mucograft® seal) and/or a restorable collagen membrane (BioGide®)will be placed to cover and stabilize the graft. Patients will return at 2 and 6 weeks post-extraction to evaluate the healing. A second CBCT will be obtained 2 weeks prior to implant placement to evaluate the ridge dimensions and compare them to the baseline data. Implant placement will take place at 12, 24 and 36 after tooth extraction for Groups 1, 2 and 3 respectively. A bone core biopsy will be obtained at the time of implant placement and will be sent for histological analysis. Patients will return for a post-operative visit at two weeks. Clinical indices (probing depth, recession, bleeding upon probing, keratinized mucosa height, plaque and gingival index), patient reported outcomes and marginal bone levels via standardized periapical radiographs will be evaluated and recorded at baseline (no more than 30 days following delivery of final implant restoration) 1, 2 and 3 years post-loading.

Conditions

Tooth Loss

Keywords

alveolar bone; alveolar ridge; bone resorption; bone grafting; barrier membrane

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Had an Implant That Survived 3 Years After Implant Placement

  For participants that had implant placement, this outcome is determined via clinical evaluation of the number of participants that still had their 1 implant in place after 3 Years. Note: Only 1 implant was placed per participant.

  3 years after implant placement

Secondary Outcomes (19)

• % of Vital Bone Via Histomorphotmetric Evaluation of Bone Core Biopsies at 3 Months

  3 months

• % of Vital Bone Via Histomorphotmetric Evaluation of Bone Core Biopsies at 6 Months

  6 months

• % of Vital Bone Via Histomorphotmetric Evaluation of Bone Core Biopsies at 9 Months

  9 months

• Amount of Mineralization Via Micro-CT Analysis 3 Months

  3 months

• Amount of Mineralization Via Micro-CT Analysis 6 Months

  6 months

Study Arms (3)

Implant placement 3 mo. after tooth ext.

EXPERIMENTAL

Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 mo. after tooth ext.

Device: xenograft (BioOss Collagen)

Implant placement 6 mo. after tooth ext.

ACTIVE COMPARATOR

Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 mo. after tooth ext.

Device: xenograft (BioOss Collagen)

Implant placement 9 mo. after tooth ext.

ACTIVE COMPARATOR

Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 mo. after tooth ext.

Device: xenograft (BioOss Collagen)

Interventions

xenograft (BioOss Collagen) DEVICE

Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)

Implant placement 3 mo. after tooth ext.; Implant placement 6 mo. after tooth ext.; Implant placement 9 mo. after tooth ext.

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• May be either male or female
• Age: 18 years or older
• Subjects with a single-rooted tooth (except mandibular incisors) indicated for extraction
• Extractions socket walls should either be intact or have no more than one bony wall (buccal or lingual) dehiscence extending no more than 50% of the total bony wall height
• Must be in adequate physical and mental health to undergo routine dental treatment including the surgical procedures associated tooth extraction and implant placement
• Subjects' treatment plan must include replacement of the tooth to be extracted with dental implant supported fixed restoration
• Subjects must have read, understood and signed an informed consent form

You may not qualify if:

• Mandibular incisors
• Acute infection associated with the tooth to be extracted or with adjacent teeth
• History of significant heart, stomach, liver, kidney, blood, immune system disease, or other organ impairment or systemic diseases that would prevent undergoing the proposed treatment or may result in compromised healing (e.g. poorly controlled diabetes, active heavy tobacco use \[\>10 cigs/day\])
• Subjects with uncontrolled and/or severe metabolic bone diseases or disorders, such as osteoporosis, thyroid disorders or Paget's disease
• Subjects taking any medication or supplement known to largely influence bone metabolism, such as IV bisphosphonates, long-term history of oral bisphosphonates or chronic intake of glucocorticoids
• Pregnant women or nursing mothers
• Subjects that are unwilling or unable to sign the informed consent
• History of lack of compliance with dental visits
• Subjects unwilling to return for the required number of visits

Sponsors & Collaborators

• University of Iowa: lead
• Geistlich Pharma AG: collaborator

Study Sites (1)

The University of Iowa College of Dentistry and Dental Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (46)

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MeSH Terms

Conditions

Tooth Loss; Bone Resorption

Interventions

Transplantation, Heterologous

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Results Point of Contact

• Title: Carlos Garaicoa Pazmino, DDS, MS
• Organization: University of Iowa

carlos-garaicoapazmino@uiowa.edu

(319) 467-4315

Study Officials

• Carlos Garaicoa Pazmino, DDS

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors collecting the data and conducting the appropriate statistical analyses for all outcomes in the study will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: September 6, 2018
• Study Start: December 10, 2018
• Primary Completion: May 22, 2025
• Study Completion: May 22, 2025
• Last Updated: March 9, 2026
• Results First Posted: March 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)