Topics

A Clinical Trial to Evaluate Kerecis Oral™ Compared to Autogenous Free Gingival Graft (AFGG) Tissue to Augment Gingival Soft Tissue and Wound Healing

2018-09-14 03:31:18 | BioPortfolio

Summary

The purpose of this study is to evaluate Omega-3 Wound™ as an alternative to autogenous free gingival grafts harvested from the palate to treat human subjects with insufficient KT (< 2 mm)

Description

Primary objective:

The primary aim will be to see if Omega-3 Wound™ is clinically superior to tissue harvested from the palate (Autogenous Free Gingival Graft) when comparing before and after measurements of: keratinized tissue. Change in KT width from time of surgery to 6 months post-surgery (22).

Secondary objectives:

1. Measures of periodontal health (probing depth, recession levels, bleeding on probing, plaque score, clinical attachment level, resistance to muscle pull, vestibular depth, healing time) over 3 months (at study entry, 4 weeks, 3 months and 6 months)

2. Time of surgery

3. Subject Discomfort Survey during healing and at 1 week and 4 weeks

4. Subject Preference Questionnaire at month 6

5. Safety endpoints assessed by monitoring adverse events

Study Design

Conditions

Mucogingival Deformity - Insufficient Keratinized Tissue

Intervention

Kerecis Oral™, Free Gingival Graft

Status

Completed

Source

Kerecis Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2018-09-14T03:31:18-0400

Clinical Trials [1880 Associated Clinical Trials listed on BioPortfolio]

Efficacy of a Modified Technique of Free Gingival Graft in Volumetric Changes of the Graft: Randomized Clinical Trial

This study will compare a new technique of free gingival graft to the original one, in order to evaluate the stability of the graft volume over one year and other variables. Twenty patient...

The Effect of Different Gingival Biotypes on Dimensional Stability of Free Gingival Graft

The aim of this study is to compare the effect of mesial and distal adjacent gingival biotypes of the tooth / teeth region of free gingival graft (FGG) on the shrinkage ratio of graft at 6...

MEBO Ointment and Hyaluronic Acid Gel in the Management of Pain After Free Gingival Graft Harvesting

Postoperative pain as well as bleeding are the most common complications after palatal graft harvesting also postsurgical swelling have been reported , Although different agents were used ...

Photobiomodulation of Palatal Donor Site After Free Gingival Graft Removal

The aim of this study is to compare the influence of two different energy densities for photobiomodulation on recovery of palatal donor area after free gingival graft technique.

Patient Outcomes and Gingival Blood Flow Using Laser Doppler Flowmetry Following the Use of Episil on Free Gingival Graft Donor Sites

The hypothesis for the present study is that patient-based outcomes and gingival blood flow will be more favorable for the free gingival graft (FGG) donor sites being covered by the test w...

PubMed Articles [11267 Associated PubMed Articles listed on BioPortfolio]

Free gingival graft and acellular dermal matrix for gingival augmentation: a 15-year clinical study.

This study evaluated clinical outcomes of acellular dermal matrix (ADM) allograft compared with autogenous free gingival graft (FGG) for gingival augmentation after 15 years.

Assessment of Creeping Attachment after Free Gingival Graft in Treatment of Isolated Gingival Recession.

This longitudinal clinical study aimed to determine the amount of creeping attachment and its relation to baseline recession depth after placement of free gingival grafts (FGG) apical to class I, II, ...

Comparison between Subepithelial Connective Tissue Graft and De-epithelialized Gingival Graft: A systematic review and a meta-analysis.

Sup-epithelial connective tissue graft (SCTG) and de-epithelialized gingival graft (DGG) approaches have been investigated with a focus on post-operative morbidity but not from a clinical outcome stan...

Pseudoaneurysm of the Greater Palatine Vessel Following Subepithelial Connective Tissue Graft.

Subepithelial gingival connective tissue grafts are a common surgical procedure performed in both periodontal and implant surgery. This versatile procedure has many indications including tooth root co...

Arthroscopic treatment of scaphoid nonunion with humpback deformity and DISI with corticocancellous bone grafting: technical note.

For two decades, scaphoid nonunion has been treated arthroscopically. However, compressed cancellous bone graft does not have the same mechanical properties as corticocancellous bone graft for reducin...

Medical and Biotech [MESH] Definitions

Generalized or localized diffuse fibrous overgrowth of the gingival tissue, usually transmitted as an autosomal dominant trait, but some cases are idiopathic and others produced by drugs. The enlarged gingiva is pink, firm, and has a leather-like consistency with a minutely pebbled surface and in severe cases the teeth are almost completely covered and the enlargement projects into the oral vestibule. (Dorland, 28th ed)

Excessive growth of the gingiva either by an increase in the size of the constituent cells (GINGIVAL HYPERTROPHY) or by an increase in their number (GINGIVAL HYPERPLASIA). (From Jablonski's Dictionary of Dentistry, 1992, p574)

The immune responses of a host to a graft. A specific response is GRAFT REJECTION.

Techniques used to expose dental surface below the gingival margin in order to obtain better dental impression during periodental and peri-implant applications. The retraction of the gingival tissue can be achieved surgically (e.g., laser gingivectomy and rotary curettage) or chemically with a retraction cord.

An abnormal extension of a gingival sulcus not accompanied by the apical migration of the epithelial attachment.

More From BioPortfolio on "A Clinical Trial to Evaluate Kerecis Oral™ Compared to Autogenous Free Gingival Graft (AFGG) Tissue to Augment Gingival Soft Tissue and Wound Healing"

Quick Search

Relevant Topics

Wound management
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...

Rheumatology
Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...


Searches Linking to this Trial