Palate; Wound
Conditions
Keywords
Hemostatic agent, Amnion-chorion membrane, Accelerated wound healing, Periodontal plastic surgery
Brief summary
The purpose of this clinical trial is to assess if donor site healing in the palatal area and patient pain perception are similar or different when using amnio-chorion membrane (ACM) on the donor site after surgery compared to a commonly used commercial hemostatic agent (ActCel Cellulose Gauze).
Detailed description
Resorbable oxidized cellulose materials are commonly used as hemostatic agents in medicine and dentistry. Surgicel and ActCel are used daily in surgical practice. When these products come in contact with blood, they convert to a gel that expands to cause direct pressure on blood vessels and control bleeding. ActCel is water-soluble and dissolves over a short time period. It can be removed easily when water, saline or hydrogen peroxide is applied.The study team will examine the effects of ACM as a wound dressing for the donor area and compare the rate of epithelialization with and without its use.
Interventions
Amnio-chorion membranes specifically for palatal wound healing following free soft tissue autografts (FTSA) procedures.
OTHERActCel Cellulose Gauze
When these products come in contact with blood, they convert to a gel that expands to cause direct pressure on blood vessels and control bleeding. ActCel is water-soluble and dissolves over a short time period. It can be removed easily when water, saline or hydrogen peroxide is applied.
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be randomly assigned to either the hemostatic agent or the amnio-chrionic membrane, but will be blinded to which standard of care intervention to which they are assigned.
Intervention model description
This is a two-independent arm, parallel-design randomized, prospective trial designed to compare two standard of care techniques.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients between age 18 and 89 * Patients needing an FSTA in the area of the mouth from 2nd molar to 2nd molar in the maxilla or mandible at sites that have teeth or implants, or in sites that are edentulous * Patients must be nonsmokers, former smokers, or current smokers who smoke \<10 cigarettes per day, by self-report * Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non- pregnant women of child-bearing potential. * Must have access to Smartphone
Exclusion criteria
* Patients who disclose that they will not be able to cooperate with the follow-up schedule. * Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report) * Pregnant women or women intending to become pregnant during study period * Smokers who smoke \> 10 cigarettes per day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing time | 1, 2, 3 and 4 weeks post-operatively | Change in Area of wound epithelialization will be measured in mm2 at 1, 2, 3 and 4 weeks postoperatively using an Early wound healing index (EHI) index. The index assesses 5 dichotomous variables, each with a yes or no assessment. Yes = score of 1; No = score of 2. Total score can range from 5 minimum to 10 maximum. The 5 variables are: * bleeding on palpation? * incomplete epithelialization? * presence of redness? * presence of swelling? * granulation tissue present? |
| Post-operative pain | 24, 48 and 72 hours post-surgery | Change in pain will be assessed post surgery using a smart-phone application that captures the pain level in a scale of 1-10, where a lower number indicates a less pain |
Countries
United States
Outcome results
None listed