Immediate Dental ImplantNCT07748494
Socket Sealing Abutment With Immediate Implant
A study testing Immediate Molar Implant Placement with Grafting Material and Immediate Molar Implant Placement without Grafting Material in people with Immediate Dental Implant and Socket Sealing, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aimed to evaluate bone and soft tissue changes clinically and radio-graphically after using socket sealing abutment with or without bone graft material. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Dental Implant, Socket Sealing, Molar Teeth
- What is being tested?
- Immediate Molar Implant Placement with Grafting Material and Immediate Molar Implant Placement without Grafting Material
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2024to 30 Aug 2025
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with non-restorable maxillary or mandibular molars indicated for extraction and replacement with implants
- Age between 18-45 years
- Sufficient inter-arch space to accommodate the future prosthesis
- Good oral hygiene
- Free from systemic diseases
- Patients with jumping space > 2 mm
Who cannot join
- Presence of any pathological lesion or root tips at the planned surgical site
- Aggressive periodontal disease
- Inadequate bone height or thickness for implant placement
- Alcohol or drug abuse
- Systemic diseases that contraindicate implant placement (e.g., osteoporosis, active cancer)
- Pregnancy
- Para-functional habits (e.g., bruxism, clenching)
- Patients wearing orthodontic appliances
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Socket Sealing Abutment in Immediate Molar Implant Placement With or Without Grafting Material
This study aimed to evaluate bone and soft tissue changes clinically and radio-graphically after using socket sealing abutment with or without bone graft material.
Read the detailed description
Immediate implant placement in molar extraction sockets poses challenges related to soft-tissue closure, jumping distance, and peri-implant tissue stability. Socket sealing abutments (SSA) have recently been introduced to enhance soft-tissue healing and maintain peri-implant architecture, with or without adjunctive bone grafting.
- Conditions
- Immediate Dental Implant, Socket Sealing, Molar Teeth
- Being tested
- Immediate Molar Implant Placement with Grafting Material, Immediate Molar Implant Placement without Grafting Material
- Keywords
- Immediate implant, Socket sealing, Soft tissue, Implant stability, Cone beam computed tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Molar Implant Placement with Grafting MaterialProcedure or surgery
Participants will receive immediate molar implant placement after tooth extraction. A socket sealing abutment will be placed, and the extraction socket will be filled with an appropriate grafting material to promote bone preservation and enhance soft tissue healing. Standard post-operative care will be provided.
Immediate Molar Implant Placement without Grafting MaterialProcedure or surgery
Participants will receive immediate molar implant placement after tooth extraction. A socket sealing abutment will be placed, without adding any grafting material. Standard post-operative care will be provided.
| Study group | Role | What they receive |
|---|---|---|
| With Grafting Material | Experimental | Placement of immediate molar implant followed by socket sealing abutment and addition of grafting material to the extraction socket. Receives: Procedure: Immediate Molar Implant Placement with Grafting Material |
| Without Grafting Material | Active comparator | Placement of immediate molar implant followed by socket sealing abutment without adding grafting material. Receives: Procedure: Immediate Molar Implant Placement without Grafting Material |
What is being measured
The primary outcome is the main question the study is designed to answer.
soft tissue changes
Optical scans of the patients' impressions were obtained immediately after surgery (baseline) and at 3- and 6-month follow-up intervals. For each patient, the baseline STL file was digitally superimposed onto the corresponding 3- and 6-month STL files using dedicated image analysis software to evaluate changes in the peri-implant soft tissues over time.
A standardized two-dimensional bucco-lingual cross-sectional image was generated along the long axis of the implant. Buccal and lingual/palatal soft tissue dimensional changes were assessed by measuring the linear distance between baseline and follow-up(3,6month) soft tissue profiles at 1, 2, 3, and 4 mm apical to the GM. Mid-buccal gingival recession was evaluated by measuring the vertical change in the position of the gingival margin at 3,6month.
Measured: Baseline,3 month,6month
Secondary outcomes (1)
Dental implant stability assessed by resonance frequency analysis (ISQ)
Implant stability will be measured using resonance frequency analysis with the Osstell device. ISQ values will be recorded immediately 3,6-month follow-up visit.
Measured: basline 3,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start15 Feb 2024
- Primary completion15 Feb 2024
- Study completion30 Aug 2025
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748494
- Sponsor's protocol ID
- SSA with immediate implant
- Status last verified
- Dec 2025
- First submitted
- 20 Dec 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socket Sealing Abutment in Immediate Molar Implant Placement With or Without Grafting Material
- ClinicalTrials.gov ID
- NCT07748494
- Acronym / sponsor ID
- SSA with immediate implant
- Conditions
- Immediate Dental Implant, Socket Sealing, Molar Teeth
- Keywords
- Immediate implant, Socket sealing, Soft tissue, Implant stability, Cone beam computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 5 Aug 2026 (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.
This study aimed to evaluate bone and soft tissue changes clinically and radio-graphically after using socket sealing abutment with or without bone graft material.
Detailed description
Immediate implant placement in molar extraction sockets poses challenges related to soft-tissue closure, jumping distance, and peri-implant tissue stability. Socket sealing abutments (SSA) have recently been introduced to enhance soft-tissue healing and maintain peri-implant architecture, with or without adjunctive bone grafting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Grafting Material | Experimental | Procedure: Immediate Molar Implant Placement with Grafting MaterialPlacement of immediate molar implant followed by socket sealing abutment and addition of grafting material to the extraction socket. |
| Without Grafting Material | Active comparator | Procedure: Immediate Molar Implant Placement without Grafting MaterialPlacement of immediate molar implant followed by socket sealing abutment without adding grafting material. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with non-restorable maxillary or mandibular molars indicated for extraction and replacement with implants
- Age between 18-45 years
- Sufficient inter-arch space to accommodate the future prosthesis
- Good oral hygiene
- Free from systemic diseases
Key exclusion criteria (8 listed)
- Presence of any pathological lesion or root tips at the planned surgical site
- Aggressive periodontal disease
- Inadequate bone height or thickness for implant placement
- Alcohol or drug abuse
- Systemic diseases that contraindicate implant placement (e.g., osteoporosis, active cancer)
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 Molar Implant Placement with Grafting MaterialParticipants will receive immediate molar implant placement after tooth extraction. A socket sealing abutment will be placed, and the extraction socket will be filled with an appropriate grafting material to promote bone preservation and enhance soft tissue healing. Standard post-operative care will be provided. | Procedure or surgery | With Grafting Material |
| Immediate Molar Implant Placement without Grafting MaterialParticipants will receive immediate molar implant placement after tooth extraction. A socket sealing abutment will be placed, without adding any grafting material. Standard post-operative care will be provided. | Procedure or surgery | Without Grafting Material |
Primary outcome
soft tissue changes
Time frame: Baseline,3 month,6month
Optical scans of the patients' impressions were obtained immediately after surgery (baseline) and at 3- and 6-month follow-up intervals. For each patient, the baseline STL file was digitally superimposed onto the corresponding 3- and 6-month STL files using dedicated image analysis software to evaluate changes in the peri-implant soft tissues over time. A standardized two-dimensional bucco-lingual cross-sectional image was generated along the long axis of the implant. Buccal and lingual/palatal soft tissue dimensional changes were assessed by measuring the linear distance between baseline and follow-up(3,6month) soft tissue profiles at 1, 2, 3, and 4 mm apical to the GM. Mid-buccal gingival recession was evaluated by measuring the vertical change in the position of the gingival margin at 3,6month.
1 secondary outcome
Dental implant stability assessed by resonance frequency analysis (ISQ)
Time frame: basline 3,6 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 15 Sep 2026.
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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 Molar Implant Placement with Grafting Material and Immediate Molar Implant Placement without Grafting Material in people with Immediate Dental Implant and Socket Sealing, run by Mansoura 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 6 inclusion and 8 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 15 Sep 2026. 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?
soft tissue changes (time frame: Baseline,3 month,6month). 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 15 Sep 2026.