Implant TherapyNCT07001813
Clinical and Radiographic Assessment of the Outcomes of Dental Implant Inserted After Xenograft Socket Preservation in Posterior Maxilla
A study testing socket preserved and non preserved socket in people with Implant Therapy, run by Suez Canal University at 1 site in Egypt.
Trial summary
Clinical and Radiographic Assessment of the Outcomes of Dental Implant Inserted after Xenograft Socket Preservation in Posterior Maxilla: A Randomized Controlled Study Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Implant Therapy
- What is being tested?
- socket preserved and non preserved socket
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 1 Dec 2024
- Phase
- Interventional
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male patients aged between 21 and 40 years.
- General good health.
- Absence of any relevant systemic disease.
- Presence of a hopeless maxillary posterior tooth that requires extraction.
- Extraction site suitable for replacement by a dental implant.
- Cases have adequate bone width and length.
- Volunteer subjects must sign an informed consent.
Who cannot join
- Poor oral hygiene with no possibility of improvement.
- Smokers (more than 10 cigarettes per day).
- Chronic treatment with any medication known to affect oral status and bone turnover.
- Drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Assessment of the Outcomes of Dental Implant Inserted After Xenograft Socket Preservation in Posterior Maxilla: A Randomized Controlled Study
Clinical and Radiographic Assessment of the Outcomes of Dental Implant Inserted after Xenograft Socket Preservation in Posterior Maxilla: A Randomized Controlled Study
Read the detailed description
Dental implants have become a common choice among the treatment options for missing teeth rehabilitation and has remarkably high survival and success rates Since the introduction of implants into clinical practice more than several decades ago. The success rate of dental implants, over the last ten years, has been about 90- 95%.
Invasive and non-invasive clinical tests are available like histomorphometric analysis, radiographic analysis, push- and pull-out tests, percussion tests, Periotest and resonance frequency analysis (RFA) are employed to assess the steadiness of dental implants to assess objectively implant stability at different stages of its service life to verify successful implantation.
- Conditions
- Implant Therapy
- Being tested
- socket preserved, non preserved socket
- Keywords
- Implant, clinical stability, radiographic assessment, soft tissue health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
socket preservedDevice
(8 cases): was treated by immediate socket preservation with S1-XB xenograft augmentation after extraction.
non preserved socketDevice
(8 cases): was not exposed to any type of socket preservation after the extraction procedure.
| Study group | Role | What they receive |
|---|---|---|
| socket preserved | Active comparator | (8 cases): was treated by immediate socket preservation with S1-XB xenograft augmentation after extraction. Receives: Device: socket preserved |
| non preserved sockets | Placebo comparator | (8 cases): was not exposed to any type of socket preservation after the extraction procedure. Receives: Device: non preserved socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical assessment of primary stability of dental implant
implant stability assessment by
- rachet insertion torque
- The implant was installed into the osteotomy site using the motorized method with the engine set at 50 rpm and 35-50 N/cm torque.
- A ratchet was used to place the implant to the desired depth when the insertion torque was more than 35N/cm torque.
- osstell device (ISQ) Make it possible to monitor osseointegration in a precise and objective manner.
- Osstell helps to objectively and non-invasively determine implant stability. The prob attached to the instrument via a cable and measurements are displayed on the black lit display.
- The device held in a right angle to the center toward the implant to be examined, the maximum deviation angle from the orthoradial direction of percussion is 45 degrees. In addition, the rod and the test surface must maintain 0.6-2.5 mm distance according to the operating instructions.
- The implant stability using OSTELL device was taken immediately postoperative and was assessed after 4 months
Measured: immediately and after four months • A ratchet was used to place the implant immediately The implant stability using OSTELL device was taken immediately postoperative implant insertion and was assessed after 4 months before prothesis
radiographic assessment of implant stability
- Pre-operative radiographic evaluation: After a healing period of four months, all the patients evaluated by Scanora 3D Cone Beam Computed Tomography scanner (CBCT) for evaluation bucco-lingual dimention, mesio-distal width, relation to neighbouring vital structures, bone density and assessment good position for implant placement. Post-operative Digital Radiography Assessment:
- Intra oral paralleling periapical direct digital radiographic procedure:
Indirect Standardized digital radiographs were achieved using KaVo Scan eXam™M One and the Rinn extension cone paralleling (XCP) periapical film holder. The KaVo Scan eXam™M One is an Intraoral digital imaging plate system (psp) system using Imaging plate which is a film-like thin, flexible, and wireless phosphorescent plate, which works as a wireless receptor.
Measured: 1.Pre-operative radiographic evaluation: before implant placement 2.Intra oral paralleling periapical direct digital radiographic procedure: immediately after placement and after four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Aug 2022
- Primary completion1 Aug 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implant TherapyStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was conducted on adults above the age of 21 years old with badly decayed posterior maxillary teeth (16 cases) requiring extraction, then subjected to implant placement. These patients were divided equally and http://www.randomizer.org randomly into two groups using Group (A) (8 cases): was treated by immediate socket preservation with S1-XB xenograft augmentation after extraction. Group (B) (8 cases): was not exposed to any type of socket preservation after the extraction procedure.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- mohamed kamel Attia, postgraduate student, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001813
- Sponsor's protocol ID
- 545/2022
- Status last verified
- May 2025
- First submitted
- 16 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
AAl MA, El Far M, Sheta NM, Fayyad A, El Desouky E, Nabi NA, Ibrahim M. Correlation of Implant Stability Between Two Noninvasive Methods Using Submerged and Nonsubmerged Healing Protocols: A Randomized Clinical Trial. J Oral Implantol. 2020 Dec 1;46(6):571-579. doi: 10.1563/aaid-joi-D-19-00130.
PubMed 33494103
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Assessment of the Outcomes of Dental Implant Inserted After Xenograft Socket Preservation in Posterior Maxilla: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07001813
- Acronym / sponsor ID
- 545/2022
- Conditions
- Implant Therapy
- Keywords
- Implant, clinical stability, radiographic assessment, soft tissue health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 3 Jun 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.
Clinical and Radiographic Assessment of the Outcomes of Dental Implant Inserted after Xenograft Socket Preservation in Posterior Maxilla: A Randomized Controlled Study
Detailed description
Dental implants have become a common choice among the treatment options for missing teeth rehabilitation and has remarkably high survival and success rates Since the introduction of implants into clinical practice more than several decades ago. The success rate of dental implants, over the last ten years, has been about 90- 95%.
Invasive and non-invasive clinical tests are available like histomorphometric analysis, radiographic analysis, push- and pull-out tests, percussion tests, Periotest and resonance frequency analysis (RFA) are employed to assess the steadiness of dental implants to assess objectively implant stability at different stages of its service life to verify successful implantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was conducted on adults above the age of 21 years old with badly decayed posterior maxillary teeth (16 cases) requiring extraction, then subjected to implant placement. These patients were divided equally and http://www.randomizer.org randomly into two groups using Group (A) (8 cases): was treated by immediate socket preservation with S1-XB xenograft augmentation after extraction. Group (B) (8 cases): was not exposed to any type of socket preservation after the extraction procedure.
| Arm | Type | Receives |
|---|---|---|
| socket preserved | Active comparator | Device: socket preserved(8 cases): was treated by immediate socket preservation with S1-XB xenograft augmentation after extraction. |
| non preserved sockets | Placebo comparator | Device: non preserved socket(8 cases): was not exposed to any type of socket preservation after the extraction procedure. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male patients aged between 21 and 40 years.
- General good health.
- Absence of any relevant systemic disease.
- Presence of a hopeless maxillary posterior tooth that requires extraction.
- Extraction site suitable for replacement by a dental implant.
Key exclusion criteria (4 listed)
- Poor oral hygiene with no possibility of improvement.
- Smokers (more than 10 cigarettes per day).
- Chronic treatment with any medication known to affect oral status and bone turnover.
- Drug or alcohol abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| socket preserved(8 cases): was treated by immediate socket preservation with S1-XB xenograft augmentation after extraction. | Device | socket preserved |
| non preserved socket(8 cases): was not exposed to any type of socket preservation after the extraction procedure. | Device | non preserved sockets |
Primary outcome
clinical assessment of primary stability of dental implant
Time frame: immediately and after four months • A ratchet was used to place the implant immediately The implant stability using OSTELL device was taken immediately postoperative implant insertion and was assessed after 4 months before prothesis
implant stability assessment by 1. rachet insertion torque * The implant was installed into the osteotomy site using the motorized method with the engine set at 50 rpm and 35-50 N/cm torque. * A ratchet was used to place the implant to the desired depth when the insertion torque was more than 35N/cm torque. 2. osstell device (ISQ) Make it possible to monitor osseointegration in a precise and objective manner. * Osstell helps to objectively and non-invasively determine implant stability. The prob attached to the instrument via a cable and measurements are displayed on the black lit display. * The device held in a right angle to the center toward the implant to be examined, the maximum deviation angle from the orthoradial direction of percussion is 45 degrees. In addition, the rod and the test surface must maintain 0.6-2.5 mm distance according to the operating instructions. * The implant stability using OSTELL device was taken immediately postoperative and was assessed after 4 months
radiographic assessment of implant stability
Time frame: 1.Pre-operative radiographic evaluation: before implant placement 2.Intra oral paralleling periapical direct digital radiographic procedure: immediately after placement and after four months
1. Pre-operative radiographic evaluation: After a healing period of four months, all the patients evaluated by Scanora 3D Cone Beam Computed Tomography scanner (CBCT) for evaluation bucco-lingual dimention, mesio-distal width, relation to neighbouring vital structures, bone density and assessment good position for implant placement. Post-operative Digital Radiography Assessment: 2. Intra oral paralleling periapical direct digital radiographic procedure: Indirect Standardized digital radiographs were achieved using KaVo Scan eXam™M One and the Rinn extension cone paralleling (XCP) periapical film holder. The KaVo Scan eXam™M One is an Intraoral digital imaging plate system (psp) system using Imaging plate which is a film-like thin, flexible, and wireless phosphorescent plate, which works as a wireless receptor.
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 3 Jun 2025.
- Results publication: PubMed 33494103AAl MA, El Far M, Sheta NM, Fayyad A, El Desouky E, Nabi NA, Ibrahim M. Correlation of Implant Stability Between Two Noninvasive Methods Using Submerged and Nonsubmerged Healing Protocols: A Randomized Clinical Trial. J Oral Implantol. 2020 Dec 1;46(6):571-579. doi: 10.1563/aaid-joi-D-19-00130.
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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.
mohamed kamel Attia, postgraduate student principal investigator
Suez Canal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing socket preserved and non preserved socket in people with Implant Therapy, run by Suez Canal 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 4 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 3 Jun 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. Some participants in this study may receive a placebo. 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?
clinical assessment of primary stability of dental implant (time frame: immediately and after four months • A ratchet was used to place the implant immediately The implant stability using OSTELL device was taken immediately postoperative implant insertion and was assessed after 4 months before prothesis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07001813, which also lists 1 linked publication.
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 3 Jun 2025.