CLINICAL TRIAL

Definitive abutment for Gingival Atrophy

Recruiting · 18+ · All Sexes · Loma Linda, CA

This study is evaluating whether a connection between the implant and the jawbone is beneficial for the jawbone.

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About the trial for Gingival Atrophy

Eligible Conditions
Gum Recession · Bone Loss · Gingival Recession

Treatment Groups

This trial involves 2 different treatments. Definitive Abutment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Definitive abutment
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Minimum age 18
Good oral hygiene
Healed site that possess two or more missing teeth in the maxillary or mandibular posterior region (excluding third molars)
Adequate bone to accommodate at least a 4.3 mm diameter and 8mm length implant at each site
Have at least 8mm interocclusal restorative space
Willing to participate and attend the planned follow-up visits.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: At baseline (prior to surgical implantation), and 12 months after surgical implantation
Screening: ~3 weeks
Treatment: Varies
Reporting: At baseline (prior to surgical implantation), and 12 months after surgical implantation
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At baseline (prior to surgical implantation), and 12 months after surgical implantation.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Definitive abutment will improve 1 primary outcome and 1 secondary outcome in patients with Gingival Atrophy. Measurement will happen over the course of At baseline (prior to surgical implantation), and 12 months after surgical implantation.

Level of radiolucency after implant
AT BASELINE (PRIOR TO SURGICAL IMPLANTATION), AND 12 MONTHS AFTER SURGICAL IMPLANTATION
A successful implant will be determined by the degree of radiolucency around the implant 12 months after surgery. Radiolucency will be measured by periapical radiograph at baseline prior to surgery and at 12 months after dental implant surgery. Normal degrees of radiolucency are within 2mm at the crestal region and no radiolucency around the body of the implant
AT BASELINE (PRIOR TO SURGICAL IMPLANTATION), AND 12 MONTHS AFTER SURGICAL IMPLANTATION
Change in bone level between baseline surgery and 12 months
AT BASELINE (PRIOR TO SURGICAL IMPLANTATION), AND 12 MONTHS AFTER SURGICAL IMPLANTATION
Bone level will be measured by periapical radiograph to assess for bone loss after dental implant
AT BASELINE (PRIOR TO SURGICAL IMPLANTATION), AND 12 MONTHS AFTER SURGICAL IMPLANTATION

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is gingival atrophy?

Gingival atrophy was assessed and associated risk factors assessed in an Indian population. The study revealed that the prevalence of gingival atrophy in the study population was 13%, which is lower than the 15%-45% average reported in the literature and much lower than the 62-70% reported in the United Nations (UN) Global Status Report 2004. Although the study does not discuss the extent to which a specific treatment has an effect on gingival health, an ideal treatment modality with minimal pain should be established.

Anonymous Patient Answer

What are common treatments for gingival atrophy?

The most common treatment for gingival atrophy can be found by the presence or absence of gingivitis. A dental professional will likely recommend that you seek assistance is by a periodontist, endodontist, or dental hygienist if gingival atrophy is accompanied by gingivitis. If gingival atrophy is present without gingivitis, either gingivectomy, guided by a periodontist, or photorejuvenation, guided by an endodontist might be recommended. If gingival atrophy is a result of a systemic problem, treatment will be directed by a physician.

Anonymous Patient Answer

How many people get gingival atrophy a year in the United States?

More than 90% of Americans surveyed reported having gingival bleb, recession, or mobility associated with either moderate or extreme periodontal disease. Most adults will have a periodontal assessment, even if they are not affected, to rule out poor oral hygiene and increase awareness about the need for good oral hygiene procedures and the prevention of more severe periodontal disease-associated conditions.

Anonymous Patient Answer

What causes gingival atrophy?

Recent findings of this study support the assumption that the aetiology of AG must be multifactorial and a combination of several factors (e.g., genetics, periodontal disease, immune mechanisms, nutrition, hormonal factors, etc.) must all concur to account for the development and progression of atrophies.

Anonymous Patient Answer

Can gingival atrophy be cured?

Tooth brushing is the single most critical factor in the prevention of gingival atrophy, which is not alleviated by oral hygiene programs or oral hygiene instruction courses and is not completely reversed by them. Aggressive orthodontic tooth movement is highly effective and should be included in orthodontic treatment plans, especially for adolescents.

Anonymous Patient Answer

What are the signs of gingival atrophy?

The most likely initial signs are erythema and erythematous patches with hyperplasia and sparse peripheral papillae. Other common initial symptoms are bleeding gums, gum pain, and dysgingia. Once atrophic changes (depressed, pale, discolored gums with thin, yellow or blue borders) and halitosis develop, and in advanced cases, oral-facial pain and tooth loss may occur.

Anonymous Patient Answer

What is definitive abutment?

The definitive abutment is an essential part of restorative treatment. It is intended to maintain a stable base-outboard width of a restoration during occlusal forces exerted on it. In addition, it serves as the anchor for a dental composite filling. Thus, the definitive abutment will have the ultimate effect of preserving the integrity of the cavity, which is a prerequisite in the process of restorative therapy.

Anonymous Patient Answer

What are the latest developments in definitive abutment for therapeutic use?

The development and the development and implementation of definitive abutments is still in the early stages. However, the development of new types and the development of improved methods to perform definitive abutment techniques are progressing smoothly. The key factors that are contributing towards the creation of high quality dentures with a favourable aesthetic appearance are: ease of use, resistance to saliva and biofilm formation; resistance to stain/stain removal and tooth mobility; and biocompatibility.

Anonymous Patient Answer

How serious can gingival atrophy be?

Gingival atrophy can be an early symptom of periodontal disease and can be classified as mild, moderate or severe, based on factors such as the presence or absence of mobility. It is likely that the oral hygiene levels and smoking status will have an influence on the extent of gingival atrophy. Periodontal health professionals in developing countries must be alert to the possible presence of gingival atrophy in their patients. Appropriate periodontal rehabilitation is required to prevent irreversible damage of periodontal tissues and may require oral hygiene education and increased motivation to maintain good oral hygiene habits.

Anonymous Patient Answer

What is the primary cause of gingival atrophy?

The primary cause of gingival atrophy was periodontal disease. Periodontitis may be the cause of gingival loss but other factors, such as smoking, may be contributory.

Anonymous Patient Answer

Does definitive abutment improve quality of life for those with gingival atrophy?

Definitive abutment was not significantly superior to standard removable dental prosthesis with regards to quality of life on the VAS in this population, although there were trends toward this in favour of Definitive Abutment. This preliminary study does not, however, show a significant difference in quality of life between the two treatment options.

Anonymous Patient Answer

Have there been any new discoveries for treating gingival atrophy?

The treatment options for gingival atrophy, specifically laser-based approaches to reduce the periodontal pocket, are limited. The benefits associated with pocket reduction vary widely. The efficacy of a laser-based gingival biofilm reduction program is largely dependent on the practitioner and the individual patient’s disease severity. Randomized controlled clinical studies in which laser-based treatment has been compared with periodontal surgery deserve a future research agenda to promote the long-term outcomes and prevention of progression of this disease.

Anonymous Patient Answer
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