Treatment of Fully Edentoulous PatientsNCT06962358
Three Years Radiographic Evaluation of Different Implant Retained Complete Over Denture Attachments (In Vivo Study)
An observational study of Treatment of Fully Edentoulous Patients, run by Tanta University at 1 site in Egypt.
Trial summary
Abstract: Treatment of completely edentulous patients with implant over dentures became a common treatment modality that greatly improves the patient's quality of life. AIM: The aim of this randomized clinical trial was to evaluate three different types of implants retained over denture attachment for three years of… Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Treatment of Fully Edentoulous Patients
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Feb 2019to 20 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Using a permuted block randomization procedure, patients were selected at random. By utilizing sealed envelopes, the individual responsible for assigning participants to the intervention arm remained oblivious to the allocation sequence and code. Somebody other than the people who took part in the study made this choice.
Who may be able to join
- Patients who have no teeth have been at least six months since their last extraction
- Having no underlying health conditions that could slow or prevent the repair of soft or hard tissues
- Cone-beam computed tomography (CBCT) confirms that each patient has an adequate amount and quality of remaining alveolar bone,
- Patients should have generally good dental hygiene
- They should have an Angel class I maxillomandibular relation with at least 20 mm of inter-arch space for telescopic attachment, and 6. mm of residual alveolar bone width in the mandibular canine sections.
- eria:
- -
Who cannot join
- The exclusion criteria of the study:
- A patient who has already undergone radiation treatment to the neck and head area.
- With the present steroid treatment
- If they have a mental or neurological disability that could make it difficult for them to practice proper dentist care.
- When a person's immune system is weak.
- I have developed parafunctional behaviors.
- In cases where the patient is highly sedentary, frequently smokes, or otherwise refuses to cooperate with treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Abstract: Treatment of completely edentulous patients with implant over dentures became a common treatment modality that greatly improves the patient's quality of life. AIM: The aim of this randomized clinical trial was to evaluate three different types of implants retained over denture attachment for three years of fellow up. Material and Methods: In a randomized prospective trial 24 completely edentulous patients of age ranged from 50-65 years were carefully selected. The patients were divided into 3 groups group A patients of implant retained over denture with telescopic attachment, Group B patients of implant retained over denture with locator attachment and Group C implant retained over denture with ball and socket attachment, over three years radiographic evaluation was carried out
Read the detailed description
According to Zarb el al., 15acrylic denture was constructed first Then a radiographic template was prepared16. Two separate CBCT (dual scan technique) images of the radiographic stent were acquired using a CAT FLX V17, Nc 28273, Kavo, Charlotte, USA. data acquired from DICOM Superimposition in implant planning software (In2guide by 3DIEMME) ® allowed for precise evaluation of implant sites in edentulous regions (virtual placement of implants considering the relation to anatomical structures and prosthetic requirements) since the prosthesis could be seen over the accessible bone architecture. , Two implants positioned vertically (Narrow sky 3512, bredent, Germany) for all patients Two healing abutments were screwed into place after the canine regions were bilaterally implanted with narrow plate forms measuring 3.5 mm in diameter and 12 mm in length. The denture was put back into place with silicon soft lining materials after 7 days of healing, and it was meant to be worn for one month. Patients who got telescopic attachments for their implant-retained overdentures were randomly assigned to one of three groups of eight patients each based on GA. (GB): the individual who got an implant-retained overdenture that has a locator attachment (Gc): the individual who got an implant-retained overdenture that has a ball and socket fixation
- Conditions
- Treatment of Fully Edentoulous Patients
- Keywords
- Implant, Over denture, Attachment, Preapical radiograph
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic evaluation
(a) In periapical radiographs, by using Digora software (DIGORA. ® for Windows2.7. SOREDEX, Finland.) the distance from the marginal osseous level to the implant platform was measured in millimeters,22 in mesial and distal aspects of each implant. During the implant platform selection process, two reference sites were made that could be readily seen and located. At a height of zero, we used a straight line that connected the two spots as our reference. Starting at zero height and continuing distally to the implant, a perpendicular line was drawn to determine the bone level. The line was then used to measure the distance from the implant to the bone.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start19 Feb 2019
- Primary completion20 Feb 2020
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Fully Edentoulous PatientsStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nashwa ali saleh, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962358
- Sponsor's protocol ID
- (#R-RP-2-24-3163).
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Years Radiographic Evaluation of Different Implant Retained Complete Over Denture Attachments (In Vivo Study)
- ClinicalTrials.gov ID
- NCT06962358
- Acronym / sponsor ID
- (#R-RP-2-24-3163).
- Conditions
- Treatment of Fully Edentoulous Patients
- Keywords
- Implant, Over denture, Attachment, Preapical radiograph
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Abstract: Treatment of completely edentulous patients with implant over dentures became a common treatment modality that greatly improves the patient's quality of life. AIM: The aim of this randomized clinical trial was to evaluate three different types of implants retained over denture attachment for three years of fellow up. Material and Methods: In a randomized prospective trial 24 completely edentulous patients of age ranged from 50-65 years were carefully selected. The patients were divided into 3 groups group A patients of implant retained over denture with telescopic attachment, Group B patients of implant retained over denture with locator attachment and Group C implant retained over denture with ball and socket attachment, over three years radiographic evaluation was carried out
Detailed description
According to Zarb el al., 15acrylic denture was constructed first Then a radiographic template was prepared16. Two separate CBCT (dual scan technique) images of the radiographic stent were acquired using a CAT FLX V17, Nc 28273, Kavo, Charlotte, USA. data acquired from DICOM Superimposition in implant planning software (In2guide by 3DIEMME) ® allowed for precise evaluation of implant sites in edentulous regions (virtual placement of implants considering the relation to anatomical structures and prosthetic requirements) since the prosthesis could be seen over the accessible bone architecture. , Two implants positioned vertically (Narrow sky 3512, bredent, Germany) for all patients Two healing abutments were screwed into place after the canine regions were bilaterally implanted with narrow plate forms measuring 3.5 mm in diameter and 12 mm in length. The denture was put back into place with silicon soft lining materials after 7 days of healing, and it was meant to be worn for one month. Patients who got telescopic attachments for their implant-retained overdentures were randomly assigned to one of three groups of eight patients each based on GA. (GB): the individual who got an implant-retained overdenture that has a locator attachment (Gc): the individual who got an implant-retained overdenture that has a ball and socket fixation
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Using a permuted block randomization procedure, patients were selected at random. By utilizing sealed envelopes, the individual responsible for assigning participants to the intervention arm remained oblivious to the allocation sequence and code. Somebody other than the people who took part in the study made this choice.
Key inclusion criteria (7 listed)
- Patients who have no teeth have been at least six months since their last extraction
- Having no underlying health conditions that could slow or prevent the repair of soft or hard tissues
- Cone-beam computed tomography (CBCT) confirms that each patient has an adequate amount and quality of remaining alveolar bone,
- Patients should have generally good dental hygiene
- They should have an Angel class I maxillomandibular relation with at least 20 mm of inter-arch space for telescopic attachment, and 6. mm of residual alveolar bone width in the mandibular canine sections.
Key exclusion criteria (7 listed)
- The exclusion criteria of the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Radiographic evaluation
Time frame: 3 year
(a) In periapical radiographs, by using Digora software (DIGORA. ® for Windows2.7. SOREDEX, Finland.) the distance from the marginal osseous level to the implant platform was measured in millimeters,22 in mesial and distal aspects of each implant. During the implant platform selection process, two reference sites were made that could be readily seen and located. At a height of zero, we used a straight line that connected the two spots as our reference. Starting at zero height and continuing distally to the implant, a perpendicular line was drawn to determine the bone level. The line was then used to measure the distance from the implant to the bone.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment of Fully Edentoulous Patients, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic evaluation (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.