Complete EdentulismNCT02881905
PeriImplant Soft Tissue and Marginal Bone Loss of Single Implant Mandibular Overdenture
A study testing ball attachment and cm loc attachment in people with Complete Edentulism, run by Cairo University at 1 site in Egypt.
Trial summary
There is a significant difference between CM LOC and ball attachment, when considering the peri-implant soft tissue health and marginal bone loss. The primary and secondary objectives are to determine if CM LOC attachment improves the peri-implant soft tissue response and decreases the marginal bone loss around… Read more about this study
- Who is it for?
- Ages 50 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- ball attachment and cm loc attachment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2016to Jul 2021
- 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 50 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Completely edentulous male or female patients between the ages of 50 to 69.
- No contraindications for implantation.
- Each patient has to perform both a random blood sugar and Glycosylated Hemoglobin analysis. Patients with a Glycosylated hemoglobin test HbA1c up to 8% and a normal blood sugar level (79 to 110) or controlled diabetic patients (90-130 fasting according to American Association of Diabetes) will be included.
- Sufficient bone width (≥ 6 mm) in the anterior region to place an implant. It could be either normally present or achieved by bone plateauing. This will be confirmed by cone beam computed tomographic (CBCT) scans.
- Residual bone height ranging from 11-20 mm with the lowest vertical height in the midline of the mandible not less than 13 mm (Class II or III according to McGarry et al[16] 1999). This will be confirmed by the CBCT.
- Patients seeking to install a single symphyseal implant and for whom new dentures will be constructed.
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- Patients, who are dissatisfied with the retention and stability of their technically satisfactory dentures.
- Patients, who already have existing maxillary and mandibular complete dentures, and after examination of the mandibular dentures, it is found that there are technical problems with regard to denture design and/or occlusion; then new maxillary and mandibular dentures will be fabricated
- All patients should have adapted to their dentures for at least six weeks before being included in the trial.
- Patients providing written informed consents to participate in the trial and this will be done before the scheduled date for implant installation.
Who cannot join
- Patients with a systemic or local contra-indication for implant placement.
- Satisfied patients with the retention of their mandibular denture as well as unsatisfied patients with their maxillary denture.
- Patient with a mandibular denture height less than 6 mm between the base of the denture and the incisal edge of the central incisors (as measured by a caliper) or with 12 mm crown height space as measured by a ruler from the incisal edge till the crest of the ridge. This will be done from a putty index of the diagnostic set up.
- Incompliant and not cooperative patients.
- Patients smoking more than 10 cigarettes per day.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient Clinic-Prosthodontic Department-Faculty of Dentistry-Cairo University
Giza
nouran abdelnaby, phd, 00201001539310, nouran.abdelnaby@dentistry.cu.edu.eg
00223642938, dentmail@dentistry.cu.edu.eg
About this study
Official title: Peri-Implant Soft Tissue Health and Marginal Bone Loss of Single Implant Mandibular Overdenture Retained by CM LOC Versus Ball Attachment: A Randomised Controlled Trial
There is a significant difference between CM LOC and ball attachment, when considering the peri-implant soft tissue health and marginal bone loss. The primary and secondary objectives are to determine if CM LOC attachment improves the peri-implant soft tissue response and decreases the marginal bone loss around implant when compared to conventional ball attachment
Read the detailed description
Ball attachments are very commonly used because they are solitary, simple, easier to use and less technique sensitive if compared to bar attachments. However, ball attachment require a prosthetic space of 12 mm and could show tremendous wear if implants were mal-aligned. CM LOC attachment is newly introduced into market with very good expectations regarding its properties and effect on the periimplant soft tissue. CM LOC attachment, which combes titanium patrix and resin matrix made from polyetherketoneketone (PEKK), is a very promising material regarding the wear and the prosthesis retention it provides, even with mal-aligned implants. However, the clinical performance of this attachment was not tested yet. Therefore, in this randomized controlled trial it was decided to compare between CM LOC and the commonly used ball attachment regarding the soft tissue health and marginal bone loss.
- Conditions
- Complete Edentulism
- Being tested
- ball attachment, cm loc attachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ball attachmentDevice
Also called metallic ball attachment
it is attachment part that connects the overdenture to the implant
cm loc attachmentDevice
It is a new attachment made of peek material
| Study group | Role | What they receive |
|---|---|---|
| ball attachment | Active comparator | completely edentulous patients having single median mandibular implant to retain mandibular overdenture.the attachment used is the conventional ball attachment Receives: Device: ball attachment |
| CM LOC attachment | Experimental | completely edentulous patients having single median mandibular implant to retain mandibular overdenture.the attachment used is the cm loc attachment Receives: Device: cm loc attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue reaction :Presence of mucositis
it is a binary outcome that is measured by either its presence or absence
Measured: [from baseline up to 1 year]
Secondary outcomes (4)
Modified gingival Index
0 = absence of inflammation
- = mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary
- = mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary
- = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary
- = severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration. Gingival units as well as the calculation of the index follow the same criteria described in GI
Measured: from baseline up to 1 year. score measurement from 0-4 where 0 is no inflammation and 4 is severe inflammation
Modified Plaque Index
Modified Plaque Index (mPI) is a dental plaque scale done by Mombelli etal.[13] as follows:
0 = No plaque
- = Separate flecks of plaque at the cervical margin
- = Plaque can be seen by naked eye
- = Abundance of soft matter. The lower the number the less plaque is present on the tooth
Measured: from baseline upto 1 year. score measurement from 0-3 where 0 denotes no plaque present and 3 denotes abundant plaque
Modified Bleeding Index
Periodontal probe will be passed all around implant cervical margin and bleeding will be scored as follows:
Score 0: No bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant.
Score 1: Isolated bleeding spots visible.
Score 2: Blood forms a confluent red line on margin.
Score 3: Heavy or profuse bleeding.
Measured: from baseline upto 1 year. score from 0-3 where 0 denotes no bleeding and 3 denotes profound bleeding
marginal bone loss
Standardized periapical long cone paralleling technique will be necessary so radiographic template customized for each patient with a holder. Then two reference points will be marked on the implant platform surface and will be joined with a line representing the height zero. then two vertical lines mesial and distal will be drawn to the first bone contact point.
Measured: from baseline up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete EdentulismStudies 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
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kiel
- Responsible party
- Principal investigator, Ahmed Salah Hamed Sherif, Cairo University
- Investigators
- nouran abdelnaby, phd, Study director, prosthodontic department-faculty of dentistry-cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881905
- Sponsor's protocol ID
- CEBD-CU-2016-8-179
- Status last verified
- Sep 2016
- First submitted
- 22 Aug 2016
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-Implant Soft Tissue Health and Marginal Bone Loss of Single Implant Mandibular Overdenture Retained by CM LOC Versus Ball Attachment: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02881905
- Acronym / sponsor ID
- CEBD-CU-2016-8-179
- Conditions
- Complete Edentulism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- University of Kiel
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 29 Aug 2016 (estimated)
- 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.
There is a significant difference between CM LOC and ball attachment, when considering the peri-implant soft tissue health and marginal bone loss. The primary and secondary objectives are to determine if CM LOC attachment improves the peri-implant soft tissue response and decreases the marginal bone loss around implant when compared to conventional ball attachment
Detailed description
Ball attachments are very commonly used because they are solitary, simple, easier to use and less technique sensitive if compared to bar attachments. However, ball attachment require a prosthetic space of 12 mm and could show tremendous wear if implants were mal-aligned. CM LOC attachment is newly introduced into market with very good expectations regarding its properties and effect on the periimplant soft tissue. CM LOC attachment, which combes titanium patrix and resin matrix made from polyetherketoneketone (PEKK), is a very promising material regarding the wear and the prosthesis retention it provides, even with mal-aligned implants. However, the clinical performance of this attachment was not tested yet. Therefore, in this randomized controlled trial it was decided to compare between CM LOC and the commonly used ball attachment regarding the soft tissue health and marginal bone loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ball attachment | Active comparator | Device: ball attachmentcompletely edentulous patients having single median mandibular implant to retain mandibular overdenture.the attachment used is the conventional ball attachment |
| CM LOC attachment | Experimental | Device: cm loc attachmentcompletely edentulous patients having single median mandibular implant to retain mandibular overdenture.the attachment used is the cm loc attachment |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Completely edentulous male or female patients between the ages of 50 to 69.
- No contraindications for implantation.
- Each patient has to perform both a random blood sugar and Glycosylated Hemoglobin analysis. Patients with a Glycosylated hemoglobin test HbA1c up to 8% and a normal blood sugar level (79 to 110) or controlled diabetic patients (90-130 fasting according to American Association of Diabetes) will be included.
- Sufficient bone width (≥ 6 mm) in the anterior region to place an implant. It could be either normally present or achieved by bone plateauing. This will be confirmed by cone beam computed tomographic (CBCT) scans.
- Residual bone height ranging from 11-20 mm with the lowest vertical height in the midline of the mandible not less than 13 mm (Class II or III according to McGarry et al[16] 1999). This will be confirmed by the CBCT.
Key exclusion criteria (5 listed)
- Patients with a systemic or local contra-indication for implant placement.
- Satisfied patients with the retention of their mandibular denture as well as unsatisfied patients with their maxillary denture.
- Patient with a mandibular denture height less than 6 mm between the base of the denture and the incisal edge of the central incisors (as measured by a caliper) or with 12 mm crown height space as measured by a ruler from the incisal edge till the crest of the ridge. This will be done from a putty index of the diagnostic set up.
- Incompliant and not cooperative patients.
- Patients smoking more than 10 cigarettes per day.
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 |
|---|---|---|
| ball attachmentAlso: metallic ball attachmentit is attachment part that connects the overdenture to the implant | Device | ball attachment |
| cm loc attachmentIt is a new attachment made of peek material | Device | CM LOC attachment |
Primary outcome
Soft tissue reaction :Presence of mucositis
Time frame: [from baseline up to 1 year]
it is a binary outcome that is measured by either its presence or absence
4 secondary outcomes
Modified gingival Index
Time frame: from baseline up to 1 year. score measurement from 0-4 where 0 is no inflammation and 4 is severe inflammation
Modified Plaque Index
Time frame: from baseline upto 1 year. score measurement from 0-3 where 0 denotes no plaque present and 3 denotes abundant plaque
Modified Bleeding Index
Time frame: from baseline upto 1 year. score from 0-3 where 0 denotes no bleeding and 3 denotes profound bleeding
marginal bone loss
Time frame: from baseline up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2016.
- 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.
nouran abdelnaby, phd study director
prosthodontic department-faculty of dentistry-cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ball attachment and cm loc attachment in people with Complete Edentulism, 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 10 inclusion and 5 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 12 Sep 2016. 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 ahmed sherif, Msc (00201002130130, ahmed.sherif@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft tissue reaction :Presence of mucositis (time frame: [from baseline up to 1 year]). 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 12 Sep 2016.