Bone Loss in JawNCT03324789
Comparison Between Single Implant Retained Partial Over-denture and Conventional Partial Denture
A study testing Single Implant Partial Over-denture and Conventional Partial Denture in people with Bone Loss in Jaw, run by Cairo University at 1 site in Egypt.
Trial summary
In this study we are going to evaluate patient satisfaction as well as the amount of bone loss on using single implant retained partial over-denture versus conventional partial denture for treatment of mandibular Kennedy class IV cases Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bone Loss in Jaw
- What is being tested?
- Single Implant Partial Over-denture and Conventional Partial Denture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mandibular long span Kennedy class IV patients
- Patients with full set of opposing dentition
- Patients having enough implant bone height
- No apparent bony mal-relation.
- No intraoral soft or hard tissue pathosis
- No uncontrolled systemic diseases such as hypertension, diabetes and immunodeficiency.
Who cannot join
- Drug or alcohol abuse
- A health condition precluding surgery
- Physical reasons that could affect follow-up
- Psychiatric problems
- Disorders to the implant area related to a history of radiation therapy to the head and neck, neoplasia, or bone augmentation to the implant site.
- Heavy smokers
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dentistry-Cairo Uni
Giza
Sheta, (+02) 23642938, cebd@dentistry.cu.edu.eg
About this study
Official title: Comparative Study Between Single Implant Retained Partial Over-denture and Conventional Partial Denture in Mandibular Long Span Kennedy Class IV ( Randomized Clinical Trial )
In this study we are going to evaluate patient satisfaction as well as the amount of bone loss on using single implant retained partial over-denture versus conventional partial denture for treatment of mandibular Kennedy class IV cases
Read the detailed description
All the procedures will be made in the outpatient clinic of the removable prosthodontics department, faculty of oral medicine, Cairo University except the CBCT will be performed in the Oral radiology department, faculty of oral medicine, Cairo University.
The selected patients will be informed of the nature of the research work and informed consent will be signed by each one of them. Only motivated patients who showed co-operation will participate in the study. Patients will be randomly divided into 2 groups.
Clinical examination and investigations will be carried out for the eligible patients including TMJ examination and intraoral examination for oral mucosa. Diagnostic charts will be prepared with full medical and dental history as well as radiographic records. The upper and lower study casts were mounted on a semi-adjustable articulator to evaluate the interarch space and the occlusal plane.
Abutment teeth will be evaluated regarding mobility, caries, existing restoration, over eruption, and malalignment. Pocket depth around the abutment teeth will be measured buccally, lingually, and proximally. Radiographic evaluation of all abutment teeth will be carried out to assess the amount of bone support, crestal bone height, continuity of lamina dura, periapical pathosis, crown/root ratio, and root form. Panoramic radiograph also to evaluate the bone quality and quantity in the lower anterior region.
All the patients will be motivated for meticulous oral hygiene.
In (Group I) The design of the finished partial overdenture will be as follows; two rests on principle abutments and lingual plate major connector. The trial of the metallic framework will be carried out for proper seat and fit.
Patients will receive anterior single implant in the mandibular sympheseal region.
The locator attachment will be inserted into the implant fixture, leaving the attachment base protruding at least 2 mm above the tissue surface. The partial overdenture will be filled with resin, and the patient will be guided to occlude in centric occlusion. The partial overdenture will be removed after the resin curing and adjusted accordingly to assure a comfortable fit.
In (Group2) The design of the finished removable partial denture will be as follows; double Aker clasp on mandibular second premolar and first molar, with no indirect retention and lingual plate as major connector .
- Conditions
- Bone Loss in Jaw
- Being tested
- Single Implant Partial Over-denture, Conventional Partial Denture
- Keywords
- Single implant, Anterior edentulism, partial denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Implant Partial Over-dentureOther
Single Implant Retained Partial Over-denture will be as follows; two rests on principle abutments and lingual plate major connector, single implant in the symphyseal region.
Conventional Partial DentureOther
patients will receive conventional partial denture with double Aker clasp on mandibular second premolar and first molar, with no indirect retention and lingual plate as major connector .
| Study group | Role | What they receive |
|---|---|---|
| Single Implant Partial Over-denture | Experimental | The design will be as follows; two rests on principle abutments and lingual plate major connector, single implant in the symphyseal region. Receives: Other: Single Implant Partial Over-denture |
| Conventional Partial Denture | Active comparator | patients will receive conventional partial denture with double Aker clasp on mandibular second premolar and first molar, with no indirect retention and lingual plate as major connector . Receives: Other: Conventional Partial Denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
will be measured using Visual Analogue Scale (VAS) , represented by a horizontal line 100 mm in length where the patient marks on the line the point that best represents their current state where the severity increases from the left to the right side of the line \& it's degree is marked according to their answers to a questionnaire of five questions prepared on how well satisfied they are with the new treatment they are receiving
Measured: six months
Secondary outcomes (1)
Bone loss
Bone height will be measured in millimeters using DIGORA machine Digital subtraction radiography will be used where Dental images will be obtained before \& after implant placement using the paralleling technique, Bone height will be measured at denture delivery, 4, 9 months respectively after denture insertions
Measured: Nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study startDec 2017 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Loss in JawStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Ahmed Abdel Wanis, Cairo University
- Investigators
- Radwa Sheta, Principal investigator, Faculty of dentistry-Cairo Uni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324789
- Sponsor's protocol ID
- 9999
- Status last verified
- Oct 2017
- First submitted
- 2 Oct 2017
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Single Implant Retained Partial Over-denture and Conventional Partial Denture in Mandibular Long Span Kennedy Class IV ( Randomized Clinical Trial )
- ClinicalTrials.gov ID
- NCT03324789
- Acronym / sponsor ID
- 9999
- Conditions
- Bone Loss in Jaw
- Keywords
- Single implant, Anterior edentulism, partial denture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 30 Oct 2017 (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.
In this study we are going to evaluate patient satisfaction as well as the amount of bone loss on using single implant retained partial over-denture versus conventional partial denture for treatment of mandibular Kennedy class IV cases
Detailed description
All the procedures will be made in the outpatient clinic of the removable prosthodontics department, faculty of oral medicine, Cairo University except the CBCT will be performed in the Oral radiology department, faculty of oral medicine, Cairo University.
The selected patients will be informed of the nature of the research work and informed consent will be signed by each one of them. Only motivated patients who showed co-operation will participate in the study. Patients will be randomly divided into 2 groups.
Clinical examination and investigations will be carried out for the eligible patients including TMJ examination and intraoral examination for oral mucosa. Diagnostic charts will be prepared with full medical and dental history as well as radiographic records. The upper and lower study casts were mounted on a semi-adjustable articulator to evaluate the interarch space and the occlusal plane.
Abutment teeth will be evaluated regarding mobility, caries, existing restoration, over eruption, and malalignment. Pocket depth around the abutment teeth will be measured buccally, lingually, and proximally. Radiographic evaluation of all abutment teeth will be carried out to assess the amount of bone support, crestal bone height, continuity of lamina dura, periapical pathosis, crown/root ratio, and root form. Panoramic radiograph also to evaluate the bone quality and quantity in the lower anterior region.
All the patients will be motivated for meticulous oral hygiene.
In (Group I) The design of the finished partial overdenture will be as follows; two rests on principle abutments and lingual plate major connector. The trial of the metallic framework will be carried out for proper seat and fit.
Patients will receive anterior single implant in the mandibular sympheseal region.
The locator attachment will be inserted into the implant fixture, leaving the attachment base protruding at least 2 mm above the tissue surface. The partial overdenture will be filled with resin, and the patient will be guided to occlude in centric occlusion. The partial overdenture will be removed after the resin curing and adjusted accordingly to assure a comfortable fit.
In (Group2) The design of the finished removable partial denture will be as follows; double Aker clasp on mandibular second premolar and first molar, with no indirect retention and lingual plate as major connector .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Implant Partial Over-denture | Experimental | Other: Single Implant Partial Over-dentureThe design will be as follows; two rests on principle abutments and lingual plate major connector, single implant in the symphyseal region. |
| Conventional Partial Denture | Active comparator | Other: Conventional Partial Denturepatients will receive conventional partial denture with double Aker clasp on mandibular second premolar and first molar, with no indirect retention and lingual plate as major connector . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Mandibular long span Kennedy class IV patients
- Patients with full set of opposing dentition
- Patients having enough implant bone height
- No apparent bony mal-relation.
- No intraoral soft or hard tissue pathosis
Key exclusion criteria (6 listed)
- Drug or alcohol abuse
- A health condition precluding surgery
- Physical reasons that could affect follow-up
- Psychiatric problems
- Disorders to the implant area related to a history of radiation therapy to the head and neck, neoplasia, or bone augmentation to the implant site.
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 |
|---|---|---|
| Single Implant Partial Over-dentureSingle Implant Retained Partial Over-denture will be as follows; two rests on principle abutments and lingual plate major connector, single implant in the symphyseal region. | Other | Single Implant Partial Over-denture |
| Conventional Partial Denturepatients will receive conventional partial denture with double Aker clasp on mandibular second premolar and first molar, with no indirect retention and lingual plate as major connector . | Other | Conventional Partial Denture |
Primary outcome
patient satisfaction
Time frame: six months
will be measured using Visual Analogue Scale (VAS) , represented by a horizontal line 100 mm in length where the patient marks on the line the point that best represents their current state where the severity increases from the left to the right side of the line \& it's degree is marked according to their answers to a questionnaire of five questions prepared on how well satisfied they are with the new treatment they are receiving
1 secondary outcome
Bone loss
Time frame: Nine months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Radwa Sheta principal investigator
Faculty of dentistry-Cairo Uni
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Implant Partial Over-denture and Conventional Partial Denture in people with Bone Loss in Jaw, run by Cairo 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 30 Oct 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheta (+2001003866631, radwasheta9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction (time frame: six 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 30 Oct 2017.