Evaluation of Marginal Bone Loss of Two Immediately Loaded Implants Retaining Mandibular Overdenture
NCT ID: NCT06150755
Last Updated: 2023-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
54 participants
INTERVENTIONAL
2023-12-24
2024-08-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The CBCT will be used to ensure sufficient bone width at the proposed implant sites, namely canine regions for implant diameter 3.7. Diagnostic set ups for all patients will be prepared to ensure a crown height space of at least 12 mm to accommodate the ball attachments for group I and intra oral welding bar for group II. Each group will receive two implants in the canine region through using surgical stent and immediate loading will be done.
Group B: immediate loading will be done using ball attachment and soft liners acting as female part for mandibular overdenture.
Group I: immediate loading will be done using intra oral welding titanium bar with 2 mm diameter and soft liner acting as a female part for mandibular overdenture.
For each group, marginal bone loss around the implants will be assessed at time of denture delivery and six months later. Patient satisfaction will be assessed using oral health related quality of life using (OHRQOL 14)
Study population
Patients' selection:
Fifty four edentulous patients will be selected from the out-patient clinic of Removable prosthodontics department, Faculty of Dentistry, Ain Shams University according to inclusion and exclusion criteria. This research will be reviewed by the research ethics committee faculty of dentistry Ain Shams University
Patients' approval:
* All patients will be informed in details about the nature of the investigation and the aim of the study. When they will agree to take part in the study, they will sign on an informed consent form.
* All participants will be given notice about their privacy practices, their legal duties and their rights.
* In case of implant treatment failure, the patients will receive a new well- fitting denture.
Study procedure
Patients' history:
* Medical history: patients will be asked about their medical and dental history through a direct interview and a detailed questionnaire sheet.
* Dental history: patients will be asked about the cause, the date of teeth extraction and if there is any previous experience with any prosthetic appliance, any problems with TMJ will also be recorded.
Patients' examination:
\- Extra oral examination:
It will be carried-out to detect any facial abnormalities, signs of inflammation and TMJ disorders as pain, clicking and limited mouth opening as well as maximum opening.
\- Intra-oral examination:
Visual examination of the denture bearing area with no flabby tissues, mucous membrane of the cheeks, lips, palate and tongue. They will be checked for no ulceration or signs of inflammation also exclude bony protuberance presence.
Radiographic evaluation and surgical guide construction:
* A panoramic x-ray of the patients preoperatively to determine if the patient is indicated for implant placement.
* Complete denture fabrication for each patient and duplication of the lower one using barium sulphate acrylic resin material to obtain radio opaque stent appliance
* A cone beam computed tomography (CBCT) scan of the patients wearing radiographic stent to evaluate the bone height, width, and density in the canine region.
Randomization and allocation concealment:
Patients will be selected randomly. The method requires the preparation of opaque sealed envelopes, containing the letter "B" and the letter "I" to represent ball attachment and the bar attachment groups respectively.
Patients will be selected according to inclusion and exclusion criteria.
Surgical procedures:
* infiltration anesthesia will be given bilaterally in the canine regions and a crestal incision will be attempted, extending from canine premolar area of one side to that of the other side. This will be done in both groups
* The flap will then be elevated and reflected using a periosteal elevator. The canine areas will be identified by the aid of the surgical guide.
* Drilling will be continued then Implants will be first hand threaded and then threaded using the torque wrench and hex tool 1.25. A minimum insertion torque of 30 Ncm is required to allow for immediate loading.
* Once the implant platform will be flushed with the crestal bone, ball abutment will be attached to the implant for group B and abutment for group I then intraoral welding will be done using 2mm titanium.
* The flap will be sutured using interrupted suturing technique.
Prosthetic insertion
* The mandibular denture will be prepared for the relining procedures by creating sufficient space in the fitting surface of the denture opposite to the attachments.
* Mollosil liner will be used to act as the female receptacle of the ball attachments in group B and intra oral welding titanium bar for group I.
* Patients will be given the following post-insertion instructions; In the first 72 hours it will be recommended to remove the denture only during oral and denture hygiene procedures. Strict oral hygiene measures should be followed by the patient..
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
mplant supported overdenture by ball attachment
immediate loaded implant supported overdenture by ball attachment
implant supported overdenture by ball
overdenture supported by two implant with ball attachment
implant supported overdenture by bar
immediate loaded implant supported overdenture by intraoral welding titanium bar splinted two implant
implant supported overdenture by bar
overdenture supported by two implant splinted by intraoral welding titanuim bar
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
implant supported overdenture by ball
overdenture supported by two implant with ball attachment
implant supported overdenture by bar
overdenture supported by two implant splinted by intraoral welding titanuim bar
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* patient will be medically free
* sufficient inter arch space
Exclusion Criteria
* TMJ disorders
* uncontrolled diabetes
* flappy tissue
40 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ain Shams University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ahmed Mostafa Abdelfatah
associate professor of oral and maxillofacial prosthodontics
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ahmed MA Mohamed, BDS MSc MD
Role: PRINCIPAL_INVESTIGATOR
Ain Shams University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty of Dentistry Ain Shams University
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FDASU-RecID032118
Identifier Type: -
Identifier Source: org_study_id