- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07601347
Effect of Immediate Placement and Loading of Compressive Versus Conventional Implants (Implants)
Effect of Immediate Placement and Loading of Compressive Versus Conventional Implants After Atraumatic Extraction Extraction (A Randomized Controlled Clinical Trial)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Oral health and oral health care are crucial for maintaining good chewing, digestion, speaking, attractiveness, and psychological well-being. The absence of one or more teeth, regardless of the cause, can have a negative impact on oral health. The most significant consequence for the patient is the compromised look, which is often the main motivation for seeking prosthodontic treatment. Tooth loss can result from various factors, such as congenital absence, trauma, dental disorders (such as caries or periodontal disease), and mechanical failure. Tooth loss can also happen as a result of associated several systemic disorders such cancer, cardiovascular disease, diabetes mellitus, and osteoporosis. Hence, it is crucial to uphold not just optimal dental hygiene, but also general well-being.
Patients may experience actual or perceived adverse consequences after the loss of one or more teeth. The psychological impacts can vary from modest to neuroticism. Tooth loss leads to a decrease in self-assurance, a tendency to avoid laughing in public, and a reluctance to establish intimate connections, particularly when the front teeth are absent.
Extensive research and clinical practice over the past few decades have unequivocally proven the effectiveness of implant dentistry. Traditionally, implants were placed in sockets that had already healed and loaded in a typical (delayed) manner.
The extraction of a tooth results in fast resorption of the alveolar ridge in both vertical and horizontal dimensions during the initial months post-extraction. In anterior teeth, reduced tissue impairs cosmetic modifications that obstruct prosthetic rehabilitation. The reduction in edge thickness, alteration of gingival contour, and loss of dental papilla, accompanied by the emergence of black gaps, are observed in these instances. Atraumatic extractions, the insertion of implants in the alveoli of excised teeth, and quick provisionalization have been suggested as alternatives to preserve tissue volume and contour, while reducing expenses and treatment duration.
Traditionally, dental implants have been submerged for a period of 3-6 months during osseointegration in order to minimize the risk of implant failure due to movements at the implant interface, as noted by Adell et al. Concerns were raised regarding the extended duration of this interval, prompting the suggestion of quick loading with a partial restoration during surgery. Nevertheless, there were significant instances of implant failure attributed to the fibrous encapsulation of the implants. Subsequent advancements in surgical technique, implant structure, and masticatory forces have provided evidence supporting the efficacy of quick loading treatments.
The concept of "Immediate loading" was introduced in the early 1990s. Today, over 15 years of clinical and histological research have proven its merits (13). The anterior mandible has been extensively researched, with a focus on immediate function, which is now considered a common operation. Nevertheless, subsequent research has indicated that this idea may be applicable to additional areas of the jaw, as long as the implant is initially stable (14, 15).
The "Compressive" implant is a singular implant featuring compressive threads. It is utilized for both single and multiple restorations with immediate loading in the maxilla and mandible, provided there is sufficient bone tissue. Implants can be positioned using either a flap or flapless technique, with the implants put subcrestally. Implant implantation is feasible immediately after tooth extraction, provided there is adequate bone tissue. It may be utilized in conjunction with Basal implants. The abutment direction may be modified by up to 15° in relation to the implant axis. Abutment of the implant specifically engineered for cement-retained prostheses.
Scientific evidence is increasingly demonstrating that osseointegration can occur in implants placed directly into recently extracted sockets. Implant dentistry has made another significant advancement with the potential for immediately loading implants into recently removed tooth sockets. Research has demonstrated that using both a bone graft and a membrane in cases where there is a bone deficiency in the area of implant placement leads to a higher quality and quantity of regenerated bone compared to using only a bone graft or a membrane alone.
An immediate implant placement refers to the placement of a dental implant directly into a socket that has just been created by the extraction of a tooth. Immediate loading refers to the process of attaching the prosthesis to the implant on the same day the implant is inserted, applying a certain amount of pressure during biting in a centered position.
Implants can be placed in fresh extraction sockets which means they can be inserted during the same visit as the tooth extraction. This approach has several benefits: it reduces complications, shortens the overall treatment time by minimizing surgical procedures, improves the patient's psychological experience, and can improve the appearance of the implant. Moreover, the timely insertion of an implant following tooth extraction can assist in preserving the bone crest and achieving optimal implant placement from a prosthetic perspective.
Existing literature indicates that the short-term survival rates for implants implanted immediately, early, delayed, or late are comparable and roughly 95%. Immediate implant insertion can be successfully performed in all areas of the jaws, however, it is more difficult to replace implants in the molar regions. Immediate implant placement can still be considered even in cases of chronic infection, as it is not an absolute contraindication.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ahmed alghandour, phd
- Phone Number: 002 01224567435
- Email: ahmed.nagi@dent.bsu.eg
Study Locations
-
-
-
Banī Suwayf, Egypt
- Recruiting
- Beni-Suef University
-
Contact:
- ahmed Beni-suef university, phd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Medically free patient
- Males and females
- Non-smoker patients
- Age ranging from 20-40 years
- Badly destructed upper premolar teeth that require implants, bone covering 2/3 of the root and of sufficient bone volume.
Exclusion Criteria:
- Patients with systemic conditions known to affect the periodontal status and healing such as uncontrolled diabetes and osteoporosis
- Heavy smokers
- Unfavorable position of the tooth or remaining roots
- Vitamin D deficiency,
- Periapical lesion/ periodontal affection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Immediate placement of conventional endosteal implants
Removal of non restorable tooth then immediate placement of conventional implants then immediate loading
|
A. The teeth will be retrieved without stress. B. The Conventional dental implant will be put directly into the alveolar bone c. Placement of healing abutment in conventional implant and measurement d. Stability measured using AnyCheck or periotest device of both implants and crestal bone level by periodontal probe postoperatively. e. Suturing f. Cone beam xray postoperatively g. Postoperative instructions and medications h. after one week immediate loading by placement of temporary pmma crown
A. The teeth will be retrieved without stress. B. The Compressive dental implant will be put directly into the alveolar bone c. Stability measured using AnyCheck or periotest device of both implants and crestal bone level by periodontal probe postoperatively. d. Suturing e. Cone beam xray postoperatively f. Postoperative instructions and medications g. after one week immediate loading by placement of temporary pmma crown |
|
Active Comparator: Immediate placement of compressive implants
Removal of non restorable tooth then immediate placement of compressive implants then immediate loading
|
A. The teeth will be retrieved without stress. B. The Conventional dental implant will be put directly into the alveolar bone c. Placement of healing abutment in conventional implant and measurement d. Stability measured using AnyCheck or periotest device of both implants and crestal bone level by periodontal probe postoperatively. e. Suturing f. Cone beam xray postoperatively g. Postoperative instructions and medications h. after one week immediate loading by placement of temporary pmma crown
A. The teeth will be retrieved without stress. B. The Compressive dental implant will be put directly into the alveolar bone c. Stability measured using AnyCheck or periotest device of both implants and crestal bone level by periodontal probe postoperatively. d. Suturing e. Cone beam xray postoperatively f. Postoperative instructions and medications g. after one week immediate loading by placement of temporary pmma crown |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
stability
Time Frame: 6 months
|
using AnyCheck Device from 1 to 100
|
6 months
|
|
Pain after the surgery
Time Frame: 6 months
|
using visual analogue scale from 1 to 10
|
6 months
|
|
Crestal Bone resorption and deposition
Time Frame: 6 months
|
using cone beam computed tomography .
|
6 months
|
|
Crestal bone loss
Time Frame: 6 months
|
using periodontal probe
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 202626
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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