Immediate ImplantsNCT06207617
Dimensional Changes Following Immediate Implant Placement in Molar Extraction Sockets With or Without Bone Graft
A study testing Immediate implant placement + customized healing abutment and Immediate implant placement + xenogeneic bone graft material + customized healing abutment in people with Immediate Implants, run by Misr International University at 1 site in Egypt.
Trial summary
Statement of problem: The majority of studies on immediate implant placement are related to the maxillary esthetic zone. Literature concerning Immediate implant placement in the posterior region is scarce. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Immediate Implants
- What is being tested?
- Immediate implant placement + customized healing abutment and Immediate implant placement + xenogeneic bone graft material + customized healing abutment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults from the age of 18 - 50 years of both genders.
- Patients with non-restorable single bounded mandibular 1st molar tooth indicated for extraction.
- Periodontally healthy patients with good oral hygiene.
- Intact interradicular bone with 2-3 mm width, assessed by CBCT.
- Thin buccal plate of bone (1 mm or less) among both of the mesial and distal root, assessed by CBCT.
- Intact gingival tissue with at least 2 mm keratinized tissue.
- Patients accepts to provide written informed consent.
Who cannot join
- Molar sites indicated for extraction with roots of close proximity to vital structures as inferior alveolar nerve.
- Pregnant females.
- Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009).
- Handicapped and mentally retarded patients.
- Patients undergoing chemotherapy and/or radiotherapy.
- Presence of systemic disease that would affect wound healing.
- Presence of active infection with soft tissue communication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
International Dental Continuing Education
Cairo
Nourhan G Dr., MSc, +201064249441, Nourhannegamal259@gmail.com
About this study
Official title: Evaluation of Soft and Hard Tissue Dimensional Changes Following Immediate Implant Placement in Molar Extraction Sockets With or Without Bone Graft: A Randomized Controlled Clinical Trial
Statement of problem: The majority of studies on immediate implant placement are related to the maxillary esthetic zone. Literature concerning Immediate implant placement in the posterior region is scarce. Furthermore, there is paucity of evidence on alveolar bone dimensional changes following immediate implant placement in fresh extraction sockets of posterior teeth. Adding to that, negligible evidence is known about the soft tissue alterations which take place during modeling and remodeling phases of socket healing process; regarding the molar sites. Nevertheless, Immediate installation into a molar socket raises an extra challenge for the clinicians, because of the different anatomical features of the extraction sockets compared to that of the single-rooted teeth in the anterior zone. In addition to, implant positioning difficulties; due to the amount of the residual inter-radicular bone after extraction. Aim of the study: To assess the bucco-lingual ridge collapse after immediate implant placement in lower 1st molar sites either with customized healing abutment only; or with xenogeneic bone graft and customized healing abutment. Materials and methods: The current study will include 28 non-restorable lower 1st molar teeth indicated for extraction in the posterior area. Patients will randomly be assigned into two equal groups: the test group; Immediate implant placement + customized healing abutment group and the control group; Immediate implant placement +bone graft+ customized healing abutment group. The presented trial will investigate the following outcomes: bucco-lingual ridge collapse as the primary outcome, together with mid-facial recession, total volume gain/loss, buccal soft tissue contour, bucco-lingual bone width, and vertical bone changes as the secondary outcomes after 12 months
Read the detailed description
After administration of local anesthesia, flapless atraumatic extraction will be performed using peristomes inserted along the root surface, apical pressure and rocking motion will be applied circumferentially to cut the periodontal ligaments. After initial luxation using Harpoon luxators, bayonet forceps will be used to deliver the tooth out of the socket. Often separation of the mesial and distal roots will be employed, to facilitate tooth delivery without impinging the soft and hard tissue architecture. Socket debridement will be done using socket curette and saline irrigation, to make sure the socket is thoroughly clean with no remnants of any periapical pathosis.
Immediate implant placement + customized healing abutment (Test group): After atraumatic extraction, flapless immediate implant of a suitable size will be placed using sequential drills of the Straumann implant system for osteotomy preparation. According to the prosthetically driven planned position, implant will be placed. Primary stability of the implant will be measured by rotational insertion torque, to be more than or equal 30 Ncm. All patients will receive an immediate anatomical customized healing abutment fabricated by adding flowable composite to the temporary cylindrical abutment mimicking the shape of the socket at the marginal gingiva, then it will be screwed to the implant.
Immediate implant placement + xenogeneic bone graft material + customized healing abutment (Control) After atraumatic extraction, immediate implant will be placed as mentioned-above, then particulate xenogeneic bone graft will be packed into the gap between the implant and the buccal plate mesially and distally. bone grafting will be up to the level of the buccal bone crest, followed by screwing the customized healing abutment.
Objectives:
- To compare Bucco-lingual ridge dimension between the two groups at baseline and one-year postoperative.
- To compare the volumetric changes in the labial soft tissue contour between the two groups assessed in mm and mm3.
- To assess and compare the Bucco-palatal bone width, and vertical bone changes in mm using cone beam computed tomography (CBCT) preoperative and at 12 Months.
- To evaluate mid facial gingival recession assessed in mm by the volumetric analysis.
- To assess peri-implant soft tissue parameters by plaque and bleeding indices.
- To assess any surgical or prosthetic complications.
- To assess Implant Failure and Implant Survival Rate
- Conditions
- Immediate Implants
- Being tested
- Immediate implant placement + customized healing abutment, Immediate implant placement + xenogeneic bone graft material + customized healing abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implant placement + customized healing abutmentProcedure or surgery
Also called IIP+customized healing abutment
Immediate implant placement in fresh extraction molar sites + customized healing abutment fabricated by adding flowable composite to the temporary cylindrical abutment mimicking the shape of the socket at the marginal gingiva, then it will be screwed to the implant. no grafting material included in this arm
Immediate implant placement + xenogeneic bone graft material + customized healing abutmentProcedure or surgery
Immediate implant placement in fresh extraction molar sites + xenogenic bone graft + customized healing abutment fabricated by adding flowable composite to the temporary cylindrical abutment mimicking the shape of the socket at the marginal gingiva, then it will be screwed to the implant.
| Study group | Role | What they receive |
|---|---|---|
| Immediate implant placement + customized healing abutment | Experimental | After atraumatic extraction, flapless immediate implant of a suitable size will be placed using sequential drills of the Straumann implant system for osteotomy preparation. According to the prosthetically driven planned position, implant will be placed. Primary stability of the implant will be measured by rotational insertion torque, to be more than or equal 30 Ncm. All patients will receive an immediate anatomical customized healing abutment fabricated by adding flowable composite to the temporary cylindrical abutment mimicking the shape of the socket at the marginal gingiva, then it will be screwed to the implant. Receives: Procedure: Immediate implant placement + customized healing abutment |
| Immediate implant placement + xenogeneic bone graft material + customized healing abutment | Active comparator | After atraumatic extraction, immediate implant will be placed as mentioned-above, then particulate xenogeneic bone graft will be packed into the gap between the implant and the buccal plate mesially and distally. bone grafting will be up to the level of the buccal bone crest, followed by screwing the customized healing abutment. Receives: Procedure: Immediate implant placement + xenogeneic bone graft material + customized healing abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bucco-lingual ridge dimension
volumetric analysis software will calculate the overall labio-palatal ridge width (mm)
Measured: 12 months
Secondary outcomes (5)
total buccal volume loss (mm3)
volumetric analysis software will calculate the overall labio-palatal ridge width (mm)
Measured: 12 months
Horizontal labio-palatal bone width
A reference line will be constructed along the palatal surface of the implant on the cross-sectional cut of the postoperative CBCT volume. Then, both initial (T0) and postoperative (T1) CBCT volumes will be superimposed on the fusion module. The horizontal labio-palatal width will be measured from the reference line to the outer labial bone at three levels below the labial bone crest: 0mm, 2mm and 5mm at T0 and T1. The difference between T1 and T0 will be calculated and compared to record the mm and % horizontal labio-palatal bone collapse.
Measured: 12 months
Vertical crestal bone level changes
a horizontal line will be placed to mark the crestal labial bone on both the initial and postoperative CBCT volumes separately. Then, both initial and postoperative CBCT volumes will be superimposed on the fusion module. A vertical linear measurement perpendicular to both lines will be done to record the mm vertical crestal bone level changes.
Measured: 12 months
mid-facial recession
using a volumetric analysis software
Measured: 12 months
linear volumetric change of buccal soft tissue contour
at 2, 4, 6mm below the free gingival margin (FGM) at baseline, 6-and 12-months postoperative. using a volumetric analysis software
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Feb 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate ImplantsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abo El Futtouh, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207617
- Sponsor's protocol ID
- IDCE.N9
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2023
- Last updated
- 28 May 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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Soft and Hard Tissue Dimensional Changes Following Immediate Implant Placement in Molar Extraction Sockets With or Without Bone Graft: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06207617
- Acronym / sponsor ID
- IDCE.N9
- Conditions
- Immediate Implants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 17 Jan 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.
Statement of problem: The majority of studies on immediate implant placement are related to the maxillary esthetic zone. Literature concerning Immediate implant placement in the posterior region is scarce. Furthermore, there is paucity of evidence on alveolar bone dimensional changes following immediate implant placement in fresh extraction sockets of posterior teeth. Adding to that, negligible evidence is known about the soft tissue alterations which take place during modeling and remodeling phases of socket healing process; regarding the molar sites. Nevertheless, Immediate installation into a molar socket raises an extra challenge for the clinicians, because of the different anatomical features of the extraction sockets compared to that of the single-rooted teeth in the anterior zone. In addition to, implant positioning difficulties; due to the amount of the residual inter-radicular bone after extraction. Aim of the study: To assess the bucco-lingual ridge collapse after immediate implant placement in lower 1st molar sites either with customized healing abutment only; or with xenogeneic bone graft and customized healing abutment. Materials and methods: The current study will include 28 non-restorable lower 1st molar teeth indicated for extraction in the posterior area. Patients will randomly be assigned into two equal groups: the test group; Immediate implant placement + customized healing abutment group and the control group; Immediate implant placement +bone graft+ customized healing abutment group. The presented trial will investigate the following outcomes: bucco-lingual ridge collapse as the primary outcome, together with mid-facial recession, total volume gain/loss, buccal soft tissue contour, bucco-lingual bone width, and vertical bone changes as the secondary outcomes after 12 months
Detailed description
After administration of local anesthesia, flapless atraumatic extraction will be performed using peristomes inserted along the root surface, apical pressure and rocking motion will be applied circumferentially to cut the periodontal ligaments. After initial luxation using Harpoon luxators, bayonet forceps will be used to deliver the tooth out of the socket. Often separation of the mesial and distal roots will be employed, to facilitate tooth delivery without impinging the soft and hard tissue architecture. Socket debridement will be done using socket curette and saline irrigation, to make sure the socket is thoroughly clean with no remnants of any periapical pathosis.
Immediate implant placement + customized healing abutment (Test group): After atraumatic extraction, flapless immediate implant of a suitable size will be placed using sequential drills of the Straumann implant system for osteotomy preparation. According to the prosthetically driven planned position, implant will be placed. Primary stability of the implant will be measured by rotational insertion torque, to be more than or equal 30 Ncm. All patients will receive an immediate anatomical customized healing abutment fabricated by adding flowable composite to the temporary cylindrical abutment mimicking the shape of the socket at the marginal gingiva, then it will be screwed to the implant.
Immediate implant placement + xenogeneic bone graft material + customized healing abutment (Control) After atraumatic extraction, immediate implant will be placed as mentioned-above, then particulate xenogeneic bone graft will be packed into the gap between the implant and the buccal plate mesially and distally. bone grafting will be up to the level of the buccal bone crest, followed by screwing the customized healing abutment.
Objectives:
- To compare Bucco-lingual ridge dimension between the two groups at baseline and one-year postoperative.
- To compare the volumetric changes in the labial soft tissue contour between the two groups assessed in mm and mm3.
- To assess and compare the Bucco-palatal bone width, and vertical bone changes in mm using cone beam computed tomography (CBCT) preoperative and at 12 Months.
- To evaluate mid facial gingival recession assessed in mm by the volumetric analysis.
- To assess peri-implant soft tissue parameters by plaque and bleeding indices.
- To assess any surgical or prosthetic complications.
- To assess Implant Failure and Implant Survival Rate
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate implant placement + customized healing abutment | Experimental | Procedure: Immediate implant placement + customized healing abutmentAfter atraumatic extraction, flapless immediate implant of a suitable size will be placed using sequential drills of the Straumann implant system for osteotomy preparation. According to the prosthetically driven planned position, implant will be placed. Primary stability of the implant will be measured by rotational insertion torque, to be more than or equal 30 Ncm. All patients will receive an immediate anatomical customized healing abutment fabricated by adding flowable composite to the temporary cylindrical abutment mimicking the shape of the socket at the marginal gingiva, then it will be screwed to the implant. |
| Immediate implant placement + xenogeneic bone graft material + customized healing abutment | Active comparator | Procedure: Immediate implant placement + xenogeneic bone graft material + customized healing abutmentAfter atraumatic extraction, immediate implant will be placed as mentioned-above, then particulate xenogeneic bone graft will be packed into the gap between the implant and the buccal plate mesially and distally. bone grafting will be up to the level of the buccal bone crest, followed by screwing the customized healing abutment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adults from the age of 18 - 50 years of both genders.
- Patients with non-restorable single bounded mandibular 1st molar tooth indicated for extraction.
- Periodontally healthy patients with good oral hygiene.
- Intact interradicular bone with 2-3 mm width, assessed by CBCT.
- Thin buccal plate of bone (1 mm or less) among both of the mesial and distal root, assessed by CBCT.
Key exclusion criteria (7 listed)
- Molar sites indicated for extraction with roots of close proximity to vital structures as inferior alveolar nerve.
- Pregnant females.
- Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009).
- Handicapped and mentally retarded patients.
- Patients undergoing chemotherapy and/or radiotherapy.
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 placement + customized healing abutmentAlso: IIP+customized healing abutmentImmediate implant placement in fresh extraction molar sites + customized healing abutment fabricated by adding flowable composite to the temporary cylindrical abutment mimicking the shape of the socket at the marginal gingiva, then it will be screwed to the implant. no grafting material included in this arm | Procedure or surgery | Immediate implant placement + customized healing abutment |
| Immediate implant placement + xenogeneic bone graft material + customized healing abutmentImmediate implant placement in fresh extraction molar sites + xenogenic bone graft + customized healing abutment fabricated by adding flowable composite to the temporary cylindrical abutment mimicking the shape of the socket at the marginal gingiva, then it will be screwed to the implant. | Procedure or surgery | Immediate implant placement + xenogeneic bone graft material + customized healing abutment |
Primary outcome
Bucco-lingual ridge dimension
Time frame: 12 months
volumetric analysis software will calculate the overall labio-palatal ridge width (mm)
5 secondary outcomes
total buccal volume loss (mm3)
Time frame: 12 months
Horizontal labio-palatal bone width
Time frame: 12 months
Vertical crestal bone level changes
Time frame: 12 months
mid-facial recession
Time frame: 12 months
linear volumetric change of buccal soft tissue contour
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 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.
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 placement + customized healing abutment and Immediate implant placement + xenogeneic bone graft material + customized healing abutment in people with Immediate Implants, run by Misr International 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 7 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: looking for participants now, as of the sponsor's last update on 28 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nourhan Gamal (01064249441, nourhannegamal259@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bucco-lingual ridge dimension (time frame: 12 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 28 May 2026.