Root CariesNCT07608497
Evaluation of Corrective Surgery Versus Dental Implants in Compromised Upper Molars
A study testing root amputation in people with Root Caries, run by Ain Shams University.
Trial summary
This study seeks to assess the clinical, radiographic, and patient-reported outcomes of root amputation 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
- What is being tested?
- root amputation
- 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
- Patients will be illegible for root amputation if they one or more of the following criteria:
- Severe vertical bone loss affecting only Mesio-buccal root of Maxillary molar.
- Through-and-through furcation involvement
- Vertical root fracture confined to a Mesio-buccal root of Maxillary molar.
- Extensive root caries affecting Mesio-buccal root of Maxillary molar.
- Endodontic failure or non- treatable perforation in Mesio-buccal root of Maxillary molar
- Extensive internal or external non- treatable root resorption related to Mesio-buccal root of Maxillary molar.
- Patients who do not meet the above criteria and present with Maxillary molars in more severely compromised conditions will be directed for extraction followed by dental implant placement.
Who cannot join
- - Uncontrolled systemic disease, immunosuppression, recent bisphosphonate use, head and neck radiotherapy.
- Patient non-compliance or poor oral hygiene.
- Heavy smoking or inability to commit to maintenance.
- Root anatomy or interradicular bone that precludes predictable root amputation; insufficient bone for implant placement that cannot be reasonably augmented.
About this study
Official title: Clinical and Radiographic Outcomes of Corrective Surgery Versus Dental Implant Treatment for Management of Compromised Permanent Maxillary Molars (An In-Vivo Study)
This study seeks to assess the clinical, radiographic, and patient-reported outcomes of root amputation versus implant over a 12 months period, generating robust evidence to guide clinical decision-making and enhance patient care.
Read the detailed description
This trial aims to compare periodontal stability, functional outcomes, complications, and patient-reported satisfaction of root amputation versus extraction followed by implant-supported single-tooth restoration. Twenty- eight patients (14 per arm) aged 20-50 with Maxillary first or second molars exhibiting Grade II-III furcation, adequate adjacent bone, and good oral hygiene will be enrolled; exclusions include uncontrolled systemic disease, heavy smoking. Participants will be randomized 1:1 Group A will receive endodontic therapy as indicated, surgical root amputation, while Group B will undergo extraction, and implant placement per standard protocols, and implant crowns. The primary outcome is survival at 12 months; secondary outcomes , clinical attachment level, radiographic bone level, peri-implant/peri-root and prosthetic complications, masticatory function, with clinical and standardized radiographic assessments at 1,3, 6 and 12 months. Data will be statistically analyzed using appropriate tests with significance set at p ≤ 0.05.
- Conditions
- Root Caries
- Being tested
- root amputation
- Medical subject headings
- Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root amputationProcedure or surgery
only one root will be amputated and the rest of the molar will be preserved
| Study group | Role | What they receive |
|---|---|---|
| root imputation | Experimental | patients in this group will do root amputation for the defective root in upper maxillary molar Receives: Procedure: root amputation |
| dental implant | No intervention | patients in this group will be directed to extraction and placement of dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
regression of clinical signs and symptoms and improvement in the bone radiographically
Disappearance of signs and symptoms including tooth mobility, pain on percussion, functional success. from zero to 10 Visual analgue scale (VAS) will be used to measure the patients pain after the procedure where zero indicated no pain and 10 indicated intorable pain and the bone will be assessed Radiographically.
regarding the implant 1ry and 2ndry stability using Any Check and mesiodistal radiographic bone changes.
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 posted27 May 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jun 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, Reem Mohamed Amr Sharaf Ali Aowad, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608497
- Sponsor's protocol ID
- 2072021
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 27 May 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 27 May 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 Maxillary Molars (An In-Vivo Study)
- ClinicalTrials.gov ID
- NCT07608497
- Acronym / sponsor ID
- 2072021
- Conditions
- Root Caries
- 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 Jun 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 27 May 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 root amputation versus implant over a 12 months period, generating robust evidence to guide clinical decision-making and enhance patient care.
Detailed description
This trial aims to compare periodontal stability, functional outcomes, complications, and patient-reported satisfaction of root amputation versus extraction followed by implant-supported single-tooth restoration. Twenty- eight patients (14 per arm) aged 20-50 with Maxillary first or second molars exhibiting Grade II-III furcation, adequate adjacent bone, and good oral hygiene will be enrolled; exclusions include uncontrolled systemic disease, heavy smoking. Participants will be randomized 1:1 Group A will receive endodontic therapy as indicated, surgical root amputation, while Group B will undergo extraction, and implant placement per standard protocols, and implant crowns. The primary outcome is survival at 12 months; secondary outcomes , clinical attachment level, radiographic bone level, peri-implant/peri-root and prosthetic complications, masticatory function, with clinical and standardized radiographic assessments at 1,3, 6 and 12 months. Data will be statistically analyzed using appropriate tests with significance set at p ≤ 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| root imputation | Experimental | Procedure: root amputationpatients in this group will do root amputation for the defective root in upper maxillary molar |
| dental implant | No intervention | –patients in this group will be directed to extraction and placement of dental implant |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients will be illegible for root amputation if they one or more of the following criteria:
- Severe vertical bone loss affecting only Mesio-buccal root of Maxillary molar.
- Through-and-through furcation involvement
- Vertical root fracture confined to a Mesio-buccal root of Maxillary molar.
- Extensive root caries affecting Mesio-buccal root of Maxillary molar.
Key exclusion criteria (4 listed)
- - Uncontrolled systemic disease, immunosuppression, recent bisphosphonate use, head and neck radiotherapy.
- Patient non-compliance or poor oral hygiene.
- Heavy smoking or inability to commit to maintenance.
- Root anatomy or interradicular bone that precludes predictable root amputation; insufficient bone for implant placement that cannot be reasonably augmented.
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 amputationonly one root will be amputated and the rest of the molar will be preserved | Procedure or surgery | root imputation |
Primary outcome
regression of clinical signs and symptoms and improvement in the bone radiographically
Time frame: 12 months
Disappearance of signs and symptoms including tooth mobility, pain on percussion, functional success. from zero to 10 Visual analgue scale (VAS) will be used to measure the patients pain after the procedure where zero indicated no pain and 10 indicated intorable pain and the bone will be assessed Radiographically. regarding the implant 1ry and 2ndry stability using Any Check and mesiodistal radiographic bone changes.
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 27 May 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
Not yet recruiting
Evaluation of Corrective Surgery Versus Dental Implants in Compromised Mandibular Molars
Root Caries, Vertical Root Fracture
Recruiting
Outcomes of Pulpotomy and Root Canal Treatment in Teeth With Symptomatic Irreversible Pulpitis
Post-operative Pain, Pulpitis - Irreversible
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 root amputation in people with Root Caries, 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 4 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 27 May 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?
regression of clinical signs and symptoms and improvement in the bone radiographically (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 27 May 2026.