Immediate Dental ImplantNCT05101941
Immediate Dental Implant Placed in the Presence of Chronic Inflammatory Periapical Lesions
A study testing Immediate dental implants in people with Immediate Dental Implant and Tooth Exratction, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Compromised teeth with periapical pathologies are removed before dental implant placement and sockets are left to heal. Some clinicians began to immediately place dental implants in fresh extraction sockets associated with chronic inflammatory periapical lesions and these studies revealed high success rates Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Immediate Dental Implant, Tooth Exratction, Periapical; Infection
- What is being tested?
- Immediate dental implants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Dec 2020to 7 Oct 2021
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients ranging from 18 to 45 years with no gender predilection agreed to come for minimum follow-up visits for 6 months.
- Adequate bone beyond teeth apices without jeopardizing any anatomical structure.
- Single rooted mandibular teeth with chronic inflammatory periapical lesions represented as periapical radiolucency, pulp necrosis, sinus tract, failed RCT.
Who cannot join
- Smokers and alcoholics.
- Medically compromised patients having uncontrolled diabetes or coagulation disorders.
- Restorable teeth.
- Periodontitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Osseointegration of Immediate Dental Implant Placed in the Presence of Chronic Inflammatory Periapical Lesions
Compromised teeth with periapical pathologies are removed before dental implant placement and sockets are left to heal.
Some clinicians began to immediately place dental implants in fresh extraction sockets associated with chronic inflammatory periapical lesions and these studies revealed high success rates
Read the detailed description
12 implants will be immediately placed in sockets associated with chronic periapical granuloma. Clinical (Wound healing, Pain, swelling, implant stability) and radiographic parameters (Peri-implant radiolucency) will be evaluated
- Being tested
- Immediate dental implants
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate dental implantsProcedure or surgery
Implants will be immediately placed in sockets associated with chronic periapical granuloma Extraction of non-restorable Teeth with periapical granuloma and socket debridement will be done then implants will be placed
| Study group | Role | What they receive |
|---|---|---|
| immediate dental implants | Experimental | Not described Receives: Procedure: Immediate dental implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Implant stability
It will be measured by implant stability meter (Osstell™)
Measured: immediately, at 3 months and 6 months
Change in peri implant radiolucency
Immediate post-operative and after 6 months CBCT will be requested in order to compare the dimension of the periapical lesion in millimeters using OnDemand system.
Measured: immediately, and 6 months
Secondary outcomes (3)
Change in pain score
It will be recorded daily for the first week through a 10-point Visual Analogue Scale (VAS) from 0 to 10 (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe).
Measured: within a week
Change in swelling status
It will be recorded daily for the first week through a 10-point scale with 4 parameters will be used.
none (no swelling), light (intraoral, localized to the treated area), moderate (extraoral swelling localized to the treated area), and severe (extraoral swelling extending beyond the treated area)
Measured: within a week
Change in Early Wound Healing Index
Using Early Wound Healing Index (EHI), it will be evaluated across weeks 2, 4 and 8.
(EHI; 1: complete flap closure-no fibrin line; 2: complete flap closure-fine fibrin line; 3: complete flap closure-fibrin clot; 4: incomplete flap closure-partial necrosis; 5: incomplete flap closure-complete necrosis).
Measured: at 2 weeks, 4 weeks, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start8 Dec 2020
- Primary completion7 Oct 2021
- Study completion7 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Dental ImplantStudies 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
- 12 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
- NCT05101941
- Sponsor's protocol ID
- Immediate implants_2020
- Status last verified
- Oct 2021
- First submitted
- 20 Oct 2021
- Last updated
- 1 Nov 2021
- 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 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Osseointegration of Immediate Dental Implant Placed in the Presence of Chronic Inflammatory Periapical Lesions
- ClinicalTrials.gov ID
- NCT05101941
- Acronym / sponsor ID
- Immediate implants_2020
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 1 Nov 2021 (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.
Compromised teeth with periapical pathologies are removed before dental implant placement and sockets are left to heal.
Some clinicians began to immediately place dental implants in fresh extraction sockets associated with chronic inflammatory periapical lesions and these studies revealed high success rates
Detailed description
12 implants will be immediately placed in sockets associated with chronic periapical granuloma. Clinical (Wound healing, Pain, swelling, implant stability) and radiographic parameters (Peri-implant radiolucency) will be evaluated
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| immediate dental implants | Experimental | Procedure: Immediate dental implants |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult patients ranging from 18 to 45 years with no gender predilection agreed to come for minimum follow-up visits for 6 months.
- Adequate bone beyond teeth apices without jeopardizing any anatomical structure.
- Single rooted mandibular teeth with chronic inflammatory periapical lesions represented as periapical radiolucency, pulp necrosis, sinus tract, failed RCT.
Key exclusion criteria (4 listed)
- Smokers and alcoholics.
- Medically compromised patients having uncontrolled diabetes or coagulation disorders.
- Restorable teeth.
- Periodontitis.
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 dental implantsImplants will be immediately placed in sockets associated with chronic periapical granuloma Extraction of non-restorable Teeth with periapical granuloma and socket debridement will be done then implants will be placed | Procedure or surgery | immediate dental implants |
Primary outcome
Change in Implant stability
Time frame: immediately, at 3 months and 6 months
It will be measured by implant stability meter (Osstell™)
Change in peri implant radiolucency
Time frame: immediately, and 6 months
Immediate post-operative and after 6 months CBCT will be requested in order to compare the dimension of the periapical lesion in millimeters using OnDemand system.
3 secondary outcomes
Change in pain score
Time frame: within a week
Change in swelling status
Time frame: within a week
Change in Early Wound Healing Index
Time frame: at 2 weeks, 4 weeks, and 8 weeks
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 1 Nov 2021.
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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.
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 dental implants in people with Immediate Dental Implant and Tooth Exratction, 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 3 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 1 Nov 2021. 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 Implant stability (time frame: immediately, at 3 months and 6 months). 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?
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 1 Nov 2021.