A Comparison of Two Socket Sealing Collagen Matrices for Extraction Socket Management

Tooth Loss Clinical Trial

Official title:

A Prospective, Randomized, Controlled, Multi-center Evaluation of Extraction Socket Management Comparing Two Socket Sealing Collagen Matrices

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03003819
• Other study ID #: GPNA0001-2016
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Tooth Loss

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