Peri-implant OsteogensisNCT04517968
Immediate Implant With Cusomized Healing Abutment
A study testing immediate implant with customized healing abutment in people with Peri-implant Osteogensis, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
evaluate clinically and radiographically the effect of customized healing abutment on peri-implant osteogenesis following immediate implant placement. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Peri-implant Osteogensis
- What is being tested?
- immediate implant with customized healing abutment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 15 Jun 2020
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range: 20 - 40 years
- Good oral hygiene
- A freshly extracted socket in the mandibular molar area.
- The gap between the implant and the bone will be at least 3-4 mm.
Who cannot join
- Acute infection (periodontitis or mucosal infection)
- Patients on radiotherapy or chemotherapy.
- Alcohol or drug abuse.
- Patient with the systemic disorder (uncontrolled Diabetes mellitus, autoimmune diseases, bone diseases, etc.)
- Smokers.
- Parafunctional habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Immediate Implant Placement Using Customized Healing Abutment (Clinical Study)
evaluate clinically and radiographically the effect of customized healing abutment on peri-implant osteogenesis following immediate implant placement.
Read the detailed description
Now a day most people want to make immediate implant after extraction, which save them time and eliminates the need of second surgery. The problem is that the jummping gap between the implant and the bone that needs bone graft, this increase the cost on the patient. In this experiment we tend to evaluate this technique which may help us in growing autogenous bone and stop the need for bone grafting.
The aim of this study is to evaluate clinically and radiographically the effect of customized healing abutment on peri-implant osteogenesis following immediate implant placement.
A clinical trial was carried out on 8 patients (20-40 years old) with freshly extracted mandibular molars. Implants were placed immediately after extraction and a customized healing abutment will be fabricated. Patients were followed up clinically and radio graphically for 6 months.
- Conditions
- Peri-implant Osteogensis
- Being tested
- immediate implant with customized healing abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implant with customized healing abutmentOther
- All patients will be operated under local anesthesia.
- Atraumatic extraction of the remaining root or tooth will be achieved.
- A careful curettage of the socket will be performed if any granulation tissue is present.
- Sequential drilling of the osteotomy site with copious irrigation will be done
- The Implant is secured in place using a torque wrench.
- Fabrication of the customized abutment with flowable composite by first placing a rubber dam between the abutment and the implant to prevent leakage of composite into the socket then start adding the composite in a manner to seal the socket.
- Finishing the composite outside the patient's mouth will be done to ensure the borders are smooth with no sharp ends.
- The abutment will be attached to the implant.
| Study group | Role | What they receive |
|---|---|---|
| immediate implant with customized healing abutment | Experimental | Not described Receives: Other: immediate implant with customized healing abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in bone density
Cone beam CT will be taken immediately and 6 months postoperatively On Demand 3d software** is used to assess:
- Crestal bone loss.
- Perapical Bone density.
Measured: at 3rd, 6th months
Secondary outcomes (1)
Change in pain
The patients will be examined using the Visual Analogue Scale (VAS). the scale is from 0-10 0 =no pain 10= most severe pain
Measured: 1st day, 1 week, 4 weeks, 6 weeks, 12 weeks and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Oct 2019
- Primary completion3 Feb 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant OsteogensisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517968
- Sponsor's protocol ID
- Immediate implants
- Status last verified
- Aug 2020
- First submitted
- 14 Aug 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immediate Implant Placement Using Customized Healing Abutment (Clinical Study)
- ClinicalTrials.gov ID
- NCT04517968
- Acronym / sponsor ID
- Immediate implants
- Conditions
- Peri-implant Osteogensis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 19 Aug 2020 (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.
evaluate clinically and radiographically the effect of customized healing abutment on peri-implant osteogenesis following immediate implant placement.
Detailed description
Now a day most people want to make immediate implant after extraction, which save them time and eliminates the need of second surgery. The problem is that the jummping gap between the implant and the bone that needs bone graft, this increase the cost on the patient. In this experiment we tend to evaluate this technique which may help us in growing autogenous bone and stop the need for bone grafting.
The aim of this study is to evaluate clinically and radiographically the effect of customized healing abutment on peri-implant osteogenesis following immediate implant placement.
A clinical trial was carried out on 8 patients (20-40 years old) with freshly extracted mandibular molars. Implants were placed immediately after extraction and a customized healing abutment will be fabricated. Patients were followed up clinically and radio graphically for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| immediate implant with customized healing abutment | Experimental | Other: immediate implant with customized healing abutment |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age range: 20 - 40 years
- Good oral hygiene
- A freshly extracted socket in the mandibular molar area.
- The gap between the implant and the bone will be at least 3-4 mm.
Key exclusion criteria (6 listed)
- Acute infection (periodontitis or mucosal infection)
- Patients on radiotherapy or chemotherapy.
- Alcohol or drug abuse.
- Patient with the systemic disorder (uncontrolled Diabetes mellitus, autoimmune diseases, bone diseases, etc.)
- Smokers.
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 |
|---|---|---|
| immediate implant with customized healing abutment* All patients will be operated under local anesthesia. * Atraumatic extraction of the remaining root or tooth will be achieved. * A careful curettage of the socket will be performed if any granulation tissue is present. * Sequential drilling of the osteotomy site with copious irrigation will be done * The Implant is secured in place using a torque wrench. * Fabrication of the customized abutment with flowable composite by first placing a rubber dam between the abutment and the implant to prevent leakage of composite into the socket then start adding the composite in a manner to seal the socket. * Finishing the composite outside the patient's mouth will be done to ensure the borders are smooth with no sharp ends. * The abutment will be attached to the implant. | Other | immediate implant with customized healing abutment |
Primary outcome
change in bone density
Time frame: at 3rd, 6th months
Cone beam CT will be taken immediately and 6 months postoperatively On Demand 3d software** is used to assess: 1. Crestal bone loss. 2. Perapical Bone density.
1 secondary outcome
Change in pain
Time frame: 1st day, 1 week, 4 weeks, 6 weeks, 12 weeks and after 6 months
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 19 Aug 2020.
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?
A study testing immediate implant with customized healing abutment in people with Peri-implant Osteogensis, run by Hams Hamed Abdelrahman 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 4 inclusion and 6 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 19 Aug 2020. 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?
change in bone density (time frame: at 3rd, 6th months). 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 19 Aug 2020.