Recruiting

Collagen Matrix & Enamel Matrix DerivativeCollagen Matrix With and Without Enamel Matrix Derivative

Sponsor:

Walter Reed National Military Medical Center

Code:

NCT03467802

Conditions

Gingival Recession

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

enamel matrix derivative

Porcine collagen matrix

Study Details

Brief summary:

The purpose of this prospective, double-blinded, randomized, split-mouth study is to compare the effectiveness of a porcine collagen matrix (CM) and coronally advanced flap (CAF) with or without the addition of enamel matrix derivative (EMD) in the treatment of Miller Class I, II, or predictable class III recession defects. One defect will receive CM + CAF + EMD (Experimental), while the other will receive CM + CAF (Control) alone. The treatment of 60 similarly sized Miller class I, II, or predictable class III recession defects on single-rooted teeth in 30 subjects using CM + CAF + EMD or CM + CAF alone will be evaluated. The subjects will be in good health, non-smokers, periodontally healthy with good oral hygiene and have no contraindications to periodontal surgery. Paired, similar sized defects on single-rooted teeth will be in the same subject and measure within 2mm of each other. One defect will be randomly assigned as the test group using CM + CAF + EMD, and the other as the control group using only CM + CAF. Clinical measurements will be made using a UNC-15 periodontal probe by calibrated, board certified periodontists and will include: probing depth (PD), clinical attachment level (CAL), vertical recession (RD), and width of keratinized tissue (KT). Percent root coverage (%RC) will be calculated. The measurements will be used to evaluate surgical outcome. Surgical outcome will also be assessed using stone models. All measurements will be taken at baseline (on the day of the surgery) and 3 and 6 months post-surgery for comparison.

Conditions

Gingival Recession

Study ID

NCT03467802

Start date

Jan 1, 2019

Status verified date

Apr, 2019

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Dec 30, 2020

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Age 18 years or over
Patient will remain in the Capital region for at least 6 months following the surgical procedure for follow up appointments
Patient must be otherwise periodontally healthy
Patient must be systemically healthy (ASA class I or II)
Patient must have no contraindications to periodontal surgery
Patient must have demonstrated good oral hygiene (plaque index <1 according to Silness and Löe)
Paired Miller Class I, II or predictable III recession defects
Bilateral, facial defects on single-rooted teeth

Exclusion Criteria:

Self-reported history of smoking within previous 6 months
Does not meet any of the preceding criteria
Female patients who are pregnant or nursing
Antibiotic medications taken within the last 6 months
History of mucogingival surgery at the sites of interest
Poor plaque control (>25% of sites)
Those with clinically significant systemic disease, which may affect healing (i.e. uncontrolled diabetes or bone metabolic disease)
Allergy to chlorhexidine gluconate (Peridex)
Does not sign study consent or HIPAA forms
Bleeding complications (e.g. hemophilia)
Warfarin therapy
History of osteoporosis or taking bisphosphonate medications
History of radiation therapy in the head and neck area
Mobile teeth beyond physiologic mobility
Facial restorations at the site to be treated
Recession defects that will require more than one 15x20mm Mucograft (per side)

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Interventions

enamel matrix derivative

Enamel matrix derivative (EMD), sold under the brand name Emdogain®, is an amelogenin derivative of embryonal porcine enamel and is FDA approved for application to root surfaces to treat recession defects. Amelogenins comprise the majority of the proteins in EMD while others such as tuftelin, ameloblastin and amelin make up the remainder. EMD is thought to mimic the role of proteins crucial to cementogenesis and root development, which may promote new gingival attachment to exposed roots. The properties of EMD may favor early healing of the soft tissue and stimulate angiogenesis.

Porcine collagen matrix

Mucograft® is a bi-layered grafting material composed of Type I and III collagen. It is derived from veterinary certified pigs, sterilized by gamma irradiation and has a low antigenicity in conjunction with good biocompatibility. The material is approximately 2.5-5mm thick and is indicated for root coverage, increasing keratinized tissue, covering of implants placed immediately and alveolar ridge reconstruction. A compact outer layer contributes to protection, structure and allows for better control during suturing; while the inner layer is thick, porous and spongy in nature, providing a suitable environment for early vascularization and promotion of cellular in-growth.

Primary outcome measure

Change in gingival recession using conventional measurements [ Time Frame: Baseline to 6 months ]
Change in root coverage using digital analysis [ Time Frame: Baseline to 6 months ]
Change in Probing Depths [ Time Frame: Baseline to 6 months ]
Change in Clinical Attachment Levels [ Time Frame: Baseline to 6 months ]
Change in Keratinized Tissue [ Time Frame: Baseline to 6 months ]

Central Contacts and Locations

Central contacts

Ryan A Kaye, DMD

3012952127 ryan.a.kaye.mil@mail.mil

Brent Tibbet, DMD

3013194831

Locations

Walter Reed NMMC

Recruiting

Bethesda, Maryland, United States, 20814

Contacts

Ryan A Kaye, DMD

301-295-2127 ryan.a.kaye.mil@mail.mil

More Information

Sponsor

Walter Reed National Military Medical Center

Last update posted

Jul 1, 2019

Last verified

Apr, 2019

Keywords

Gingival Recession
Enamel Matrix Derivative
Porcine Collagen Matrix

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed National Military Medical Center on 2019-07-01.