Dental ImplantNCT06281535
Early Versus Conventional Loading for Fully Guided Immediate Implant Placement
A study testing Implant loading in people with Dental Implant, run by Ain Shams University.
Trial summary
Conventional loading protocol following implant placement 3 -6 months is considered the gold standard. However, early loading following 2 months after implant placement decreases the time and had a good survival rate. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Dental Implant
- What is being tested?
- Implant loading
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2024to 15 Jun 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients age range from 20-60 years.
- Molar tooth to be extracted due to periodontal diseases, peri- apical diseases, Endo-perio diseases, or tooth fracture.
- Primary implant stability is above 30 Ncm.
Who cannot join
- History or presence of severe uncontrolled systemic disease.
- Heavy smokers (>10 cigarettes per day) or alcohol/drug abusers.
- Poor oral hygiene.
- Acute periapical infection.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Early Versus Conventional Loading for Fully Guided Immediate Implant Placement in Molar Sites (A Randomized Controlled Clinical Study)
Conventional loading protocol following implant placement 3 -6 months is considered the gold standard. However, early loading following 2 months after implant placement decreases the time and had a good survival rate.
Read the detailed description
The conventional loading protocol presented involves healing period of 3 -6 months. A healing period without stress was recommended in the order to present better survival rate. This loading protocol was developed in the time when micro- and macro design of implant surface was machine produced. Early loading of dental implants within 2 months following placement on healed posterior mandible showed 100% survival rate for five years follow up, with uneventful crestal bone loss. The lack of difference between conventional loading 6 months following implant placement and early loading could be explained by the fact that even if the crowns were not put in direct occlusion, patients used them functionally when chewing. The most relevant factor which may explain the positive results obtained in this trial is the high insertion torque at implant placement.
- Conditions
- Dental Implant
- Being tested
- Implant loading
- Keywords
- early loading, conventional loading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant loadingDevice
Placement of abutments and final restorations either 2 months following implant placement in early loading group or 3 months in conventional loading group
| Study group | Role | What they receive |
|---|---|---|
| Early loading group | Experimental | The surgical treatment protocol entails atraumatic tooth extraction, fixture insertion and placement of the final restoration 2 months following implant placement. Receives: Device: Implant loading |
| Conventional loading group | Active comparator | The surgical treatment protocol entails atraumatic tooth extraction, fixture insertion and placement of the final restoration 3 months following implant placement. Receives: Device: Implant loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability
Degree of implant stability will be measured by Osstell device as a scale from 1 to 100
Measured: 2 and 3 months following implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start20 Feb 2024 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Principal investigator, Doaa Adel Salah Khattab, Ain Shams University
- Investigators
- Doaa Adel-Khattab, PhD, Study chair, Associate Professor Faculty of Dentistry, Ain Shams UniversityAbdel Rahman Khalaf, PhD, Principal investigator, Lecturer of Faculty of Dentistry, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281535
- Sponsor's protocol ID
- 21789
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Conventional Loading for Fully Guided Immediate Implant Placement in Molar Sites (A Randomized Controlled Clinical Study)
- ClinicalTrials.gov ID
- NCT06281535
- Acronym / sponsor ID
- 21789
- Conditions
- Dental Implant
- Keywords
- early loading, conventional loading
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 20 Feb 2024 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 28 Feb 2024 (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.
Conventional loading protocol following implant placement 3 -6 months is considered the gold standard. However, early loading following 2 months after implant placement decreases the time and had a good survival rate.
Detailed description
The conventional loading protocol presented involves healing period of 3 -6 months. A healing period without stress was recommended in the order to present better survival rate. This loading protocol was developed in the time when micro- and macro design of implant surface was machine produced. Early loading of dental implants within 2 months following placement on healed posterior mandible showed 100% survival rate for five years follow up, with uneventful crestal bone loss. The lack of difference between conventional loading 6 months following implant placement and early loading could be explained by the fact that even if the crowns were not put in direct occlusion, patients used them functionally when chewing. The most relevant factor which may explain the positive results obtained in this trial is the high insertion torque at implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early loading group | Experimental | Device: Implant loadingThe surgical treatment protocol entails atraumatic tooth extraction, fixture insertion and placement of the final restoration 2 months following implant placement. |
| Conventional loading group | Active comparator | Device: Implant loadingThe surgical treatment protocol entails atraumatic tooth extraction, fixture insertion and placement of the final restoration 3 months following implant placement. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients age range from 20-60 years.
- Molar tooth to be extracted due to periodontal diseases, peri- apical diseases, Endo-perio diseases, or tooth fracture.
- Primary implant stability is above 30 Ncm.
Key exclusion criteria (4 listed)
- History or presence of severe uncontrolled systemic disease.
- Heavy smokers (>10 cigarettes per day) or alcohol/drug abusers.
- Poor oral hygiene.
- Acute periapical infection.
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 |
|---|---|---|
| Implant loadingPlacement of abutments and final restorations either 2 months following implant placement in early loading group or 3 months in conventional loading group | Device | Conventional loading group, Early loading group |
Primary outcome
Implant stability
Time frame: 2 and 3 months following implant placement
Degree of implant stability will be measured by Osstell device as a scale from 1 to 100
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Dental Implant
Recruiting
Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
Peri Implant Mucositis, Dental Implant Rehabilitation
Not yet recruitingPhase 1/2
Effect of Povidone Iodine on the Dental Implant Internal Surface Microbiome
Dental Implant
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
RecruitingObservational study
Movement of Dental Implants During Osseointegration
Dental Implants, Osseointegration
RecruitingPhase 2/3
Lactoferrin Nanohydrogel for Soft And Hard Tissue Healing and Implant Stability in Immediate Implant Placement
Dental Implant, Wound Healing
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.
Doaa Adel-Khattab, PhD study chair
Associate Professor Faculty of Dentistry, Ain Shams University
Abdel Rahman Khalaf, PhD principal investigator
Lecturer of Faculty of Dentistry, Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Implant loading in people with Dental Implant, run by Ain Shams University.
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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doaa Adel-Khattab, PhD (01006814258, dr.doaa.adel-khattab@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant stability (time frame: 2 and 3 months following implant placement). 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 28 Feb 2024; AzTrials last refreshed its copy on 30 Oct 2026.