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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.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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
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.

Egypt1 site
  • Faculty of Dentistry, Tanta University

    Tanta, 3111

Other trials in Egypt

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 groups in NCT07658144
Study groupRoleWhat they receive
Root guide techniqueExperimentalten 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 techniqueExperimentalten 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.

  1. 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

  2. soft tissue healing

    soft tissue healing evaluated clinically in both groups presence of dehiscence and exposure of bone or not

    Measured: one week

  3. infection

    infection evaluated clinically in both groups presence of signs of infection or not

    Measured: one week-one month

  4. density of bone

    density of bone calculated radiographically in both groups CBCT

    Measured: six months]

Secondary outcomes (1)
  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.

  1. First posted18 Jun 2026
  2. Study start22 Mar 2025
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion10 Jul 2026 (estimated)

Resources

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)
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

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.

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