Immediate Implant Placement in Maxillary Molar RegionNCT07658144
Evaluation of the Accuracy of Root Guided Immediate Implant Placement at Maxillary- Molar Region
A study testing root guide technique and surgical guide technique in people with Immediate Implant Placement in Maxillary Molar Region, run by Tanta University at 1 site in Egypt.
Trial summary
Twenty patients with non restorable maxillary molar that indicate to immediate implant will be included in this study. The patients will be divided randomly (10 patients each group). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Implant Placement in Maxillary Molar Region
- What is being tested?
- root guide technique and surgical guide technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Mar 2025to 10 Jul 2026
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Patients with non-restorable maxillary molars.
- Age of patients above 18 years old.
- Good oral hygiene.
- Healthy covering keratinized oral mucosa.
Who cannot join
- • Patients with systemic disease that may affect bone healing.
- Periapical pathosis.
- Heavy smoker patients(>14 cigarettes per day).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Twenty patients with non restorable maxillary molar that indicate to immediate implant will be included in this study. The patients will be divided randomly (10 patients each group). Group I(study),immediate implant placement will be done using root guide technique.Group II(control),immediate implant placement will be done using surgical guide technique.The patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department,Faculty of Dentistry, Tanta University.The patients will be evaluated clinically to evaluate healing and radio graphically using cone beam CT (CBCT) scan to identify bone density post operative and after 6 months.
Read the detailed description
Purpose: This study aimed to evaluate the accuracy of the root guide technique in comparison to the surgical guide technique for immediate implant placement in the maxillary- molar region radiographically and clinically.
Materials \& Methods:Twenty patients with non restorable maxillary molar will be included in this study. The patients will be divided randomly (10 patients each group). Group I,immediate implant placement will be done using root guide technique.Group II,immediate implant placement will be done using surgical guide technique.The patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department,Faculty of Dentistry, Tanta University.The patients will be evaluated clinically to evaluate healing and radio graphically using cone beam CT (CBCT) scan to identify bone density post operative and after 6 months.
Preoperative evaluation: The patients will be evaluated clinically and radiographically using Cone beam CT(CBCT) scan , before implant placement for assessment of the anatomy of inter-radicular septum and tooth roots ,periapical pathology , bone density and approximation of vital structures , then we will make virtual planning to future implant position.
- fabrication of surgical guide stent( tooth born ): will be done for Group II, Conventional impression will be taken with irreversible hydrocolloid to make a diagnostic cast.
- The cast will be scanned with a laboratory scanner.
- -The scanned data of the cast will exported as a standard tessellation language (STL) file, while the CBCT image will saved as Digital Imaging and Communications in Medicine (DICOM) data 26 .
- -Design of the surgical guide proceeded with superimposition of the STL file to the CBCT data through a software [Blue Sky software].⃰
- -Completion of virtual implant treatment planning with proper adjustment, the adequate position of the implant will planned with the creation of open sleeve.
- -Selection and fabrication of surgical guide based on the computed tomography model and print it by Creality LD006 ⃰⃰
Surgical procedure:
Stage 1:
Group I:
All patients will undergo the surgery under local anesthesia. We will do coronctomy to the level of free gingiva and separation of the roots with surgical fissure bur ,drilling the implant site according to manufacture's proptocl will be done with roots intact in their sockets within the inter-radicular bone. Clinically visible roots will be extracted by using periotomes .Following extraction, the socket will be debrided to remove any reminants and the socket and osteotomy will be irrigated by sterile normal saline . The implant will be inserted into the site following manufacture's protocol.
GroupII All patients will undergo the surgery under local anesthesia. Surgical separation of the roots will be done by surgical fissure bur , separated roots will be extracted by periotomes , the socket will be debrided to remove any reminants and irrigated by sterile normal saline. Following extraction, drilling the implant site will be done through the surgical guide (tooth supported surgical guide) according to manufacturer's protocol, implant will be inserted into the site following manufactures protocol.
- After insertion of the implant in both groups: the primary stability will be measured by Osstell device (resonance frequency analyzer, (RFA) is a device that uses resonance frequency analysis to measure implant stability quotient (ISQ)) , then we will fill the gap between the implant and walls of the socket by bone graft graft(xenogeneic bone graft) and PRF (platelets- rich fibrin) around the implant into the socket , finally custom mad haling abutment will b made.
Postoperative evaluation: The patients will be evaluated clinically regarding healing, presence of inflammation,and swelling each week at the first month then after 3 months and 6 months and assess pain, by Visual Analog Scale weekly during the first month (at days 1,7, and14). . Implant stability will be assessed at the time of implant insertion and 6 months after the operation.
Radiographically,During the follow-up period a CBCT will be taken immediately postoperative and 6 months after the operation.
Immediate CBCT was to compare the actual position of the implant with the preoperative virtual planning of the implant position by superimposition of preoperative and postoperative CBCT. Three deviation parameters between each planned and placed implant were measured :
- Horizontal deviation at coronal side of the implant.
- Horizontal deviation at apex of the implant
- Angular deviation. All measurements were performed using Mimics Innovation Suite 19tm software.
Stage II( crest module uncoverage and healing abutment installation).:
After 6 months of consolidation and osseointegration period, CBCT was done to assess the oseteointegration . A surgical re-entry procedure performed to allow access to the crest module of the fixture.
Prior to the start of surgery, the patient rinsed his mouth with betadine for 1 min. The oral cavity was scrubbed with betadine (povidine iodine 2.5%) antiseptic solution.
Under local anesthesia ,custom made healing abutment was removed to exposure the implant . Smart peg was installed at the fixture level to assess secondary implant stability before loading.A healing abutment selected according to the soft tissue thickness installed until gingival collar becomes adequate around the implant.
.
- Being tested
- root guide technique, surgical guide technique
- Keywords
- immediate implant , root guide technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root guide techniqueDevice
group I ten patients with non restorable maxillary molar will be undergo placement of immediate implant by using root guide for drilling of the ostoetomy site.
surgical guide techniqueDevice
group II ten patients with non restorable maxillary molar will be undergo placement of immediate implant by using surgical guide for drilling of the ostoetomy site.
| Study group | Role | What they receive |
|---|---|---|
| Root guide technique | Experimental | ten patients with non restorable maxillary molar which indicated to immediate implant were treated by using root guide technique for placement of immediate implant . Drilling the implant site according to protocol of manufacture was done with roots intact in their sockets within the inter-radicular bone Receives: Device: root guide technique |
| surgical guide technique | Experimental | ten patients with non restorable maxillary molar which indicated to immediate implant were treated by using surgical guide.Drilling the implant site according to protocol of manufacture was done through the surgical guide after extraction of roots. Receives: Device: surgical guide technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of pain
degree of pain evaluated clinically in both groups using visual analogue scale:0 represent no pain and 10 represents the highest level of pain
Measured: one-two weeks
soft tissue healing
soft tissue healing evaluated clinically in both groups presence of dehiscence and exposure of bone or not
Measured: one week
infection
infection evaluated clinically in both groups presence of signs of infection or not
Measured: one week-one month
density of bone
density of bone calculated radiographically in both groups CBCT
Measured: six months]
Secondary outcomes (1)
inflammation
inflammation clinically in both groups 0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start22 Mar 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion10 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Implant Placement in Maxillary Molar RegionStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Rizk Zakaria Nasef, Tanta University
- Investigators
- Abeer R Nasef, doctor, Principal investigator, Tanta Universality
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658144
- Sponsor's protocol ID
- 2243
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 18 Jun 2026
- 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 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of Root Guided Immediate Implant Placement at Maxillary- Molar Region
- ClinicalTrials.gov ID
- NCT07658144
- Acronym / sponsor ID
- 2243
- Keywords
- immediate implant , root guide technique
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 22 Mar 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 18 Jun 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.
Twenty patients with non restorable maxillary molar that indicate to immediate implant will be included in this study. The patients will be divided randomly (10 patients each group). Group I(study),immediate implant placement will be done using root guide technique.Group II(control),immediate implant placement will be done using surgical guide technique.The patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department,Faculty of Dentistry, Tanta University.The patients will be evaluated clinically to evaluate healing and radio graphically using cone beam CT (CBCT) scan to identify bone density post operative and after 6 months.
Detailed description
Purpose: This study aimed to evaluate the accuracy of the root guide technique in comparison to the surgical guide technique for immediate implant placement in the maxillary- molar region radiographically and clinically.
Materials \& Methods:Twenty patients with non restorable maxillary molar will be included in this study. The patients will be divided randomly (10 patients each group). Group I,immediate implant placement will be done using root guide technique.Group II,immediate implant placement will be done using surgical guide technique.The patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department,Faculty of Dentistry, Tanta University.The patients will be evaluated clinically to evaluate healing and radio graphically using cone beam CT (CBCT) scan to identify bone density post operative and after 6 months.
Preoperative evaluation: The patients will be evaluated clinically and radiographically using Cone beam CT(CBCT) scan , before implant placement for assessment of the anatomy of inter-radicular septum and tooth roots ,periapical pathology , bone density and approximation of vital structures , then we will make virtual planning to future implant position.
- fabrication of surgical guide stent( tooth born ): will be done for Group II, Conventional impression will be taken with irreversible hydrocolloid to make a diagnostic cast.
- The cast will be scanned with a laboratory scanner.
- -The scanned data of the cast will exported as a standard tessellation language (STL) file, while the CBCT image will saved as Digital Imaging and Communications in Medicine (DICOM) data 26 .
- -Design of the surgical guide proceeded with superimposition of the STL file to the CBCT data through a software [Blue Sky software].⃰
- -Completion of virtual implant treatment planning with proper adjustment, the adequate position of the implant will planned with the creation of open sleeve.
- -Selection and fabrication of surgical guide based on the computed tomography model and print it by Creality LD006 ⃰⃰
Surgical procedure:
Stage 1:
Group I:
All patients will undergo the surgery under local anesthesia. We will do coronctomy to the level of free gingiva and separation of the roots with surgical fissure bur ,drilling the implant site according to manufacture's proptocl will be done with roots intact in their sockets within the inter-radicular bone. Clinically visible roots will be extracted by using periotomes .Following extraction, the socket will be debrided to remove any reminants and the socket and osteotomy will be irrigated by sterile normal saline . The implant will be inserted into the site following manufacture's protocol.
GroupII All patients will undergo the surgery under local anesthesia. Surgical separation of the roots will be done by surgical fissure bur , separated roots will be extracted by periotomes , the socket will be debrided to remove any reminants and irrigated by sterile normal saline. Following extraction, drilling the implant site will be done through the surgical guide (tooth supported surgical guide) according to manufacturer's protocol, implant will be inserted into the site following manufactures protocol.
- After insertion of the implant in both groups: the primary stability will be measured by Osstell device (resonance frequency analyzer, (RFA) is a device that uses resonance frequency analysis to measure implant stability quotient (ISQ)) , then we will fill the gap between the implant and walls of the socket by bone graft graft(xenogeneic bone graft) and PRF (platelets- rich fibrin) around the implant into the socket , finally custom mad haling abutment will b made.
Postoperative evaluation: The patients will be evaluated clinically regarding healing, presence of inflammation,and swelling each week at the first month then after 3 months and 6 months and assess pain, by Visual Analog Scale weekly during the first month (at days 1,7, and14). . Implant stability will be assessed at the time of implant insertion and 6 months after the operation.
Radiographically,During the follow-up period a CBCT will be taken immediately postoperative and 6 months after the operation.
Immediate CBCT was to compare the actual position of the implant with the preoperative virtual planning of the implant position by superimposition of preoperative and postoperative CBCT. Three deviation parameters between each planned and placed implant were measured :
- Horizontal deviation at coronal side of the implant.
- Horizontal deviation at apex of the implant
- Angular deviation. All measurements were performed using Mimics Innovation Suite 19tm software.
Stage II( crest module uncoverage and healing abutment installation).:
After 6 months of consolidation and osseointegration period, CBCT was done to assess the oseteointegration . A surgical re-entry procedure performed to allow access to the crest module of the fixture.
Prior to the start of surgery, the patient rinsed his mouth with betadine for 1 min. The oral cavity was scrubbed with betadine (povidine iodine 2.5%) antiseptic solution.
Under local anesthesia ,custom made healing abutment was removed to exposure the implant . Smart peg was installed at the fixture level to assess secondary implant stability before loading.A healing abutment selected according to the soft tissue thickness installed until gingival collar becomes adequate around the implant.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Root guide technique | Experimental | Device: root guide techniqueten patients with non restorable maxillary molar which indicated to immediate implant were treated by using root guide technique for placement of immediate implant . Drilling the implant site according to protocol of manufacture was done with roots intact in their sockets within the inter-radicular bone |
| surgical guide technique | Experimental | Device: surgical guide techniqueten patients with non restorable maxillary molar which indicated to immediate implant were treated by using surgical guide.Drilling the implant site according to protocol of manufacture was done through the surgical guide after extraction of roots. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Patients with non-restorable maxillary molars.
Key exclusion criteria (3 listed)
- • Patients with systemic disease that may affect bone healing.
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 |
|---|---|---|
| root guide techniquegroup I ten patients with non restorable maxillary molar will be undergo placement of immediate implant by using root guide for drilling of the ostoetomy site. | Device | Root guide technique |
| surgical guide techniquegroup II ten patients with non restorable maxillary molar will be undergo placement of immediate implant by using surgical guide for drilling of the ostoetomy site. | Device | surgical guide technique |
Primary outcome
degree of pain
Time frame: one-two weeks
degree of pain evaluated clinically in both groups using visual analogue scale:0 represent no pain and 10 represents the highest level of pain
soft tissue healing
Time frame: one week
soft tissue healing evaluated clinically in both groups presence of dehiscence and exposure of bone or not
infection
Time frame: one week-one month
infection evaluated clinically in both groups presence of signs of infection or not
density of bone
Time frame: six months]
density of bone calculated radiographically in both groups CBCT
1 secondary outcome
inflammation
Time frame: one week
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 18 Jun 2026.
Related trials for Immediate Implant Placement in Maxillary Molar Region
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Comparing 7 mm and 5 mm Implants Placed Immediately After Molar Extraction
Partial Edentulism in the Maxilla or in the Mandible, Immediate Implant Placement
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.
Abeer R Nasef, doctor principal investigator
Tanta Universality
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing root guide technique and surgical guide technique in people with Immediate Implant Placement in Maxillary Molar Region, run by Tanta 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 4 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 18 Jun 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?
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?
degree of pain (time frame: one-two weeks). The study lists 4 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 18 Jun 2026.