Minimally Invasive Flap Procedure + Emdogain for Gum Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Texas A&M University
Must not be taking: Healing inhibitors
Disqualifiers: Pregnancy, Breastfeeding, Serious medical conditions, others
Trial Summary
What is the purpose of this trial?This trial tests if using Emdogain® MI gel in a minimally invasive gum procedure can improve healing and attachment of gums in patients with moderate gum disease. The gel is applied after cleaning the roots of the teeth to help reduce inflammation and promote reattachment. Emdogain has been used in various clinical studies to promote periodontal tissue regeneration, including cementum, periodontal ligament, and alveolar bone.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that are known to inhibit or slow healing.
What data supports the effectiveness of the treatment Minimally Invasive Flap Procedure + Emdogain for Gum Disease?
Research shows that Emdogain, an enamel matrix derivative, can help regenerate periodontal tissues, leading to improved healing and reduced inflammation after gum surgery. Clinical trials have indicated that using Emdogain with surgical procedures can result in better outcomes compared to surgery alone.
12345Is the Minimally Invasive Flap Procedure with Emdogain safe for treating gum disease?
Research shows that Emdogain, used in gum disease treatments, generally has a good safety profile with no reported complications like allergic reactions or infections in studies. However, there have been rare cases of external inflammatory resorption, a condition where the root of the tooth is damaged, following its use.
13567How does the treatment Minimally Invasive Flap Procedure + Emdogain for gum disease differ from other treatments?
This treatment is unique because it combines a minimally invasive surgical approach with Emdogain, an enamel matrix protein derivative, which promotes the regeneration of periodontal tissues and improves healing by reducing inflammation. Emdogain has been shown to enhance the regeneration of the periodontium, leading to better outcomes compared to surgery alone.
12367Eligibility Criteria
This trial is for adults aged 30-75 with moderate gum disease, specifically isolated pocket depths of 5-7 mm on certain teeth and at least 2 mm of attachment loss. Participants should be in good health, not have had antibiotics or gum treatments recently, smoke less than 10 cigarettes a day, and not be pregnant or breastfeeding.Inclusion Criteria
I have gum disease with some areas around my teeth measuring 5 to less than 7 mm deep.
At least 2 mm of attachment loss
Good health
+5 more
Exclusion Criteria
Smoke more than ten cigarettes per day
Breastfeeding
Pregnant
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo a non-incised minimally invasive flap procedure with Emdogain® MI or traditional SRP with videoscope visualization
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with evaluations at 1 week, 3 months, and 6 months
6 months
3 visits (in-person)
Postoperative Evaluation
Postoperative evaluation at 1 week to reinforce oral hygiene and take photographs
1 week
1 visit (in-person)
Participant Groups
The study tests a minimally invasive flap procedure to treat gum disease using Emdogain® MI versus the same procedure without Emdogain. It involves removing part of the sulcus lining and cleaning the root surface with visual aid from a videoscope.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Periodontal regenerationExperimental Treatment1 Intervention
Regeneration will be attempted during root scaling and planing with the application of Emdogain and the use of a Videoscope.
Group II: ControlPlacebo Group1 Intervention
The control group will receive standard-of-care root scaling and planing without the application of Emdogain and the use of a Videoscope.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Texas A&M School of DentistryDallas, TX
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Who Is Running the Clinical Trial?
Texas A&M UniversityLead Sponsor
Institut Straumann AGIndustry Sponsor
References
Inflammatory external root resorption following surgical treatment for intra-bony defects: a report of two cases involving Emdogain and a review of the literature. [2006]Enamel matrix-derived proteins have been shown to regenerate periodontal tissues lost as a result of disease in humans. Emdogain, a commercial preparation of porcine enamel matrix derivative (EMD), has been shown to induce new cementum, periodontal ligament and bone formation in human periodontal defects. Although a number of studies have reported successful outcomes, local adverse effects have so far not been reported in the literature. This case report describes two examples of external inflammatory resorption following surgical root surface debridement and the use of Emdogain.
Effect of an enamel matrix protein derivative (Emdogain) on ex vivo dental plaque vitality. [2019]A common clinical observation following surgical periodontal therapy with an enamel matrix derivative (Emdogain) is the improved healing of the soft tissues and the limited inflammation of the operated areas. These clinical observations are empirical and difficult to explain. One of the factors influencing the early wound healing might be a potential antimicrobial effect of Emdogain.
Emdogain: evidence of efficacy. [2011]This article addresses the use of enamel matrix proteins (Emdogain) to enhance regeneration of the periodontium. Information regarding the role of Emdogain to induce cementogenesis and histologic evidence in animals and humans that it can initiate regeneration of diseased sites are discussed. Several clinical trials have indicated that Emdogain plus modified Widman flap surgery provide a better result than the surgery alone. Several other investigations have indicated that flap surgery plus Emdogain or a bioabsorbable membrane achieve similar results. However, this latter finding needs further validation. Clinical examples of successful therapy with Emdogain are presented.
Use of Emdogain in the treatment of deep intrabony defects: 12-month clinical results. Histologic and radiographic evaluation. [2016]The objective of this study was to evaluate the application of an enamel matrix derivative (Emdogain) in deep periodontal pocket therapy. Twenty-one patients presenting intrabony and interproximal defects that could be treated with guided tissue regeneration were selected. The intrabony defects were divided into deep ( or = 9 mm) defects. Bleeding on probing, Plaque Index, probing pocket depth, mobility index, gingival recession, probing attachment level, and surgical bone level were measured at baseline. At 12 months, cases were reexamined and indices recorded again. The mean probing depth decreased from 8.1 +/- 2.1 mm to 3.2 +/- 1.5 mm; attachment level decreased from 10.4 +/- 2.4 mm to 7.0 +/- 1.8 mm; recession increased from 2.3 +/- 1.4 mm to 3.8 +/- 1.8 mm; and surgical bone level decreased from 9.6 +/- 1.9 mm to 7.1 +/- 1.5 mm. No significant difference wa noted between bone defects with one or 2 walls, between local and generalized periodontitis, or between smokers and nonsmokers. Significant statistical difference was found, however, between deep intrabony defects and very deep defects when attachment gain was considered. No adverse reaction to the substance was noted. The good clinical results obtained were not confirmed by radiologic results; standardized and computerized radiographs at 12 months did not reveal significant improvement. The histologic examination carried out on 2 samples did not show evidence of new attachment. Further studies are necessary to clarify the action mechanism and to evaluate the long-term results of this method.
Enamel matrix derivative: a review of cellular effects in vitro and a model of molecular arrangement and functioning. [2012]Enamel matrix derivative (EMD), the active component of Emdogain®, is a viable option in the treatment of periodontal disease owing to its ability to regenerate lost tissue. It is believed to mimic odontogenesis, though the details of its functioning remain the focus of current research.
Treatment of intrabony periodontal defects with an enamel matrix protein derivative (Emdogain): a report of 32 cases. [2004]Enamel matrix proteins, including Emdogain, have been proposed as a new modality for regenerative periodontal treatment. However, limited information is available concerning the clinical applicability and therapeutic results with Emdogain. The aim of the present study was therefore to evaluate the clinical outcome following the application of Emdogain in the treatment of intrabony periodontal defects. Twenty-eight patients with marginal periodontitis (thirty-two 2- and 3-walled intrabony defects) were included in this study. The following parameters were evaluated prior to treatment and 8 months after treatment: probing pocket depth, recession of the gingival margin, and clinical attachment level. The postoperative healing phase was uneventful in all cases. There were no complications such as allergic reactions, abscess formation, or infections throughout the entire study period. The mean probing pocket depth was reduced from 8.7 +/- 1.5 mm at baseline to 4.3 +/- 1.6 mm after 8 months (P
Five years clinical results following treatment of human intra-bony defects with an enamel matrix derivative: a randomized controlled trial. [2013]Emdogain® represents an extracellular matrix derivative that controls and promotes periodontal regeneration. Several studies have demonstrated that the treatment of periodontal defects with Emdogain® leads to improvements in clinical parameters. However, long-time clinical trials establishing clinical usefulness of Emdogain® are scarce. Therefore, the present randomized split mouth, controlled study was undertaken to evaluate the effectiveness of Emdogain® as an adjunct to open flap debridement for the treatment of intra-bony defects over a period of 5 years.