Root CariesNCT07633834
Evaluation of Corrective Surgery Versus Dental Implants in Compromised Mandibular Molars
A study testing hemi sectioning in people with Root Caries and Vertical Root Fracture, run by Ain Shams University.
Trial summary
This study seeks to assess the clinical, radiographic, and patient-reported outcomes of hemisection versus implant over a 12 months period, generating robust evidence to guide clinical decision-making and enhance patient care. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Caries, Vertical Root Fracture
- What is being tested?
- hemi sectioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Jan 2028
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good oral hygiene and motivation for follow-up care.
- Ability to understand and sign informed consent.
- Localized Root/Periodontal Disease: Severe attachment loss or bone loss (e.g., severe localized periodontitis) affecting the mesial root, while the other root remains healthy.
- Furcation Involvement: Class II or III furcation involvements where the disease cannot be treated by conventional methods.
- Vertical root fracture confined to the mesial root.
- Non-treatable perforation in the mesial root.
- Extensive sub-gingival root caries affecting the mesial root.
- Extensive un-treatable internal and external root resorption related to the mesial root.
Who cannot join
- Uncontrolled systemic diseases (e.g., diabetes mellitus, bleeding disorders, immunosuppression).
- Fused or poorly shaped roots,
- Active periodontal or endodontic infection at adjacent teeth that may interfere with treatment outcomes.
- Severe bruxism or occlusal parafunction.
- History of radiation therapy in the head and neck region.
- Pregnancy or lactation.
- Poor compliance or inability to attend follow-up visits.
- Smoking more than 10 cigarettes per day.
About this study
Official title: Clinical and Radiographic Outcomes of Corrective Surgery Versus Dental Implant Treatment for Management of Compromised Permanent Mandibular Molars (An In-vivo Study)
This study seeks to assess the clinical, radiographic, and patient-reported outcomes of hemisection versus implant over a 12 months period, generating robust evidence to guide clinical decision-making and enhance patient care.
- Conditions
- Root Caries, Vertical Root Fracture
- Being tested
- hemi sectioning
- Medical subject headings
- Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemi sectioningProcedure or surgery
one root will be extracted and the other root will be preserved
| Study group | Role | What they receive |
|---|---|---|
| Hemisection | Experimental | patients in this group will have hemi sectioning to their compromised mandibular molars Receives: Procedure: hemi sectioning |
| dental implants | No intervention | patients will undergo extraction and replaced with dental implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Regulation of clinical signs and symptoms
Patient-reported outcomes, including satisfaction, masticatory efficiency, and oral comfort measured by a visual analog scale (VAS).
Measured: 12 months
Secondary outcomes (1)
Assessment of radiographic bone changes
- Radiographic bone level changes around the retained root or implant.
- Detection of any radiographic signs of pathology or treatment failure. Measurements will be recorded in millimeters (mm) using digital radiographic software calibration tools.
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 posted8 Jun 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root CariesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yomna tarek, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633834
- Sponsor's protocol ID
- 2991994
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 8 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes of Corrective Surgery Versus Dental Implant Treatment for Management of Compromised Permanent Mandibular Molars (An In-vivo Study)
- ClinicalTrials.gov ID
- NCT07633834
- Acronym / sponsor ID
- 2991994
- Conditions
- Root Caries, Vertical Root Fracture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 8 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.
This study seeks to assess the clinical, radiographic, and patient-reported outcomes of hemisection versus implant over a 12 months period, generating robust evidence to guide clinical decision-making and enhance patient care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemisection | Experimental | Procedure: hemi sectioningpatients in this group will have hemi sectioning to their compromised mandibular molars |
| dental implants | No intervention | –patients will undergo extraction and replaced with dental implants |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Good oral hygiene and motivation for follow-up care.
- Ability to understand and sign informed consent.
- Localized Root/Periodontal Disease: Severe attachment loss or bone loss (e.g., severe localized periodontitis) affecting the mesial root, while the other root remains healthy.
- Furcation Involvement: Class II or III furcation involvements where the disease cannot be treated by conventional methods.
- Vertical root fracture confined to the mesial root.
Key exclusion criteria (8 listed)
- Uncontrolled systemic diseases (e.g., diabetes mellitus, bleeding disorders, immunosuppression).
- Fused or poorly shaped roots,
- Active periodontal or endodontic infection at adjacent teeth that may interfere with treatment outcomes.
- Severe bruxism or occlusal parafunction.
- History of radiation therapy in the head and neck region.
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 |
|---|---|---|
| hemi sectioningone root will be extracted and the other root will be preserved | Procedure or surgery | Hemisection |
Primary outcome
• Regulation of clinical signs and symptoms
Time frame: 12 months
Patient-reported outcomes, including satisfaction, masticatory efficiency, and oral comfort measured by a visual analog scale (VAS).
1 secondary outcome
Assessment of radiographic bone changes
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 8 Jun 2026.
Related trials for Root Caries
Not yet recruiting
Clinical Performance of High Viscous Glass Ionomer Cervical Restorations With Silver-Modified Atraumatic Restorative Technique (SMART) Versus Conventional Treatment in Elderly Cancer Patients. (A 12-month Randomized Clinical Trial)
Dental Caries, Cervical Caries
Not yet recruiting
Clinical Performance of Two HEMA-Free Universal Adhesive Systems
Cervical Caries
Recruiting
Outcomes of Pulpotomy and Root Canal Treatment in Teeth With Symptomatic Irreversible Pulpitis
Post-operative Pain, Pulpitis - Irreversible
Not yet recruiting
Evaluation of Corrective Surgery Versus Dental Implants in Compromised Upper Molars
Root Caries
Not yet recruiting
Clinical Evaluation of Self-Adhesive Flowable Giomer With and Without Selective Enamel Etching
Cervical Caries
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing hemi sectioning in people with Root Caries and Vertical Root Fracture, 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 8 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: opening soon, as of the sponsor's last update on 8 Jun 2026. 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?
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?
• Regulation of clinical signs and symptoms (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 8 Jun 2026.