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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03003819
Other study ID # GPNA0001-2016
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date June 2020

Study information

Verified date February 2020
Source McGuire Institute
Contact Diego Velasquez, DDS, MSD
Phone 810.750.3500
Email Periomichigan@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A prospective RCT of intact extractions with delayed implant placement comparing extraction socket management effectiveness and office economics of two collagen matrices. Soft tissue wound healing will be assessed out to 4-months post-operative, when implants will be placed.


Description:

A prospective, randomized, multi-center, controlled clinical study of intact extractions (bony dehiscences <1/3 socket apico-coronal and mesial-distal dimension) with delayed implant placement. Study objective: to compare extraction socket management effectiveness and office economics of a frequently used wound dressing (control) with a soft tissue augmentation matrix (test) in 32-64 subjects 18 -75 years of age with intact (bony dehiscence, if present, < 1/3 socket dimension) extractions intended for dental implant replacement. Following screening subjects will undergo tooth extraction and randomization to either the control or test therapy. After treatment, subjects will be followed until 4- months, the time of implant placement. Primary outcome: soft tissue wound healing measured by (1) gap closure and (2) graft containment at all time points.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date June 2020
Est. primary completion date April 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Subject indicated for anterior tooth extraction (from premolars forward) intended for implant placement.

- Subjects with essentially intact extraction sockets - bony dehiscences < 1/3 the depth of socket and mesial-distal width of tooth socket

- Subjects will have read, understood and signed an institutional review board (IRB) approved Informed Consent Form (ICF).

- Subjects must be able and willing to follow study procedures and instructions

Exclusion Criteria:

- Subjects with healing disorders (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) that could compromise wound healing and/ or preclude implant surgery; or who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.

- Subjects taking intramuscular or intravenous bisphosphonates.

- Subjects who have a known allergy or sensitivity to collagen.

- Subjects with acute, suppurative lesions with pain, swelling and apical lesions > 5mm will be excluded, though antibiotic prophylaxis may be employed to reduce infection and provide possible subject reconsideration for inclusion.

- Heavy smokers/tobacco users defined as those smoking = 10 cigarettes or = 4 cigars or = 4 pipes per day. For non-heavy smokers, smoking = 10 cigarettes or = 4 cigars or = 4 pipes per day is prohibited for the duration of the study.

- Female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration

- Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental).

- Subjects, who in the opinion of the Investigator, for any reason other than those listed above, will not be able to complete the study per protocol.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Control Collagen Wound Dressing
Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic and local anesthetic, minimally traumatic extraction will be performed with periotomes . After degranulation and bone graft placement, control or test biomaterial will be placed according to the randomization schedule and surgical instructions for each biomaterial.
Test Collagen Matrix
Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic and local anesthetic, minimally traumatic extraction will be performed with periotomes . After degranulation and bone graft placement, control or test biomaterial will be placed according to the randomization schedule and surgical instructions for each biomaterial.

Locations

Country Name City State
United States Seven Lakes Periodontics Fenton Michigan

Sponsors (1)

Lead Sponsor Collaborator
McGuire Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

Sclar AG. Strategies for management of single-tooth extraction sites in aesthetic implant therapy. J Oral Maxillofac Surg. 2004 Sep;62(9 Suppl 2):90-105. Erratum in: J Oral Maxillofac Surg. 2005 Jan;63(1):158. — View Citation

Thoma DS, Sancho-Puchades M, Ettlin DA, Hämmerle CH, Jung RE. Impact of a collagen matrix on early healing, aesthetics and patient morbidity in oral mucosal wounds - a randomized study in humans. J Clin Periodontol. 2012 Feb;39(2):157-65. doi: 10.1111/j.1600-051X.2011.01823.x. Epub 2011 Dec 6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Socket Soft Tissue Gap Closure - linear measures buccal-lingual in millimeters Longitudinal extraction socket soft tissue gap closure measured buccal-lingual from baseline to 4-months. 4-months
Secondary Socket Soft Tissue Gap Closure - linear measures mesial-distal Longitudinal extraction socket soft tissue gap closure measured mesial-distal from baseline to 4-months. 4-months
Secondary Graft Containment as observed by subject and examiner (yes/ no) 4-months
Secondary Inflammation Score (Loe and Sillness) 4-months
Secondary Biomaterial Integrity - 4-point scale Score 0-4, 0 = biomaterial completely present, 4 = no evidence of biomaterial/ complete granulation or other tissue 4-months
Secondary Tissue Thickness - probe show-thru at baseline and biopsy measure in millimeters at 4-months Soft tissue thickness is measured using probe "show-thru" (tissue transparency) at baseline and soft tissue biopsy at the implant site immediately prior to implant placement 4-months
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