Inclined ImplantsNCT05695612

EVALUATION OF TWO DIFFERENT ATTACHMENT SYSTEMS IN MANDIBULAR OVERDENTURES RETAINED WITH TWO INCLINED IMPLANTS

A study testing Novaloc Attachment and Locator Attachment in people with Inclined Implants, run by Alexandria University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

The aim of the study is to evaluate clinically and radiographically the Novaloc and Locator attachment systems in mandibular overdentures retained with two inclined implants. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Inclined Implants
What is being tested?: Novaloc Attachment and Locator Attachment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteEgypt
Study dates: 10 Mar 2022to Jun 2023
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients should be completely edentulous.
Patients should have enough bone for the placement of implants at least 3.5 mm in diameter and 10.0 mm in length.
Patients should be co-operative and have adequate dexterity for placement and removal of the implant -retained overdenture.
The inter-ridge space should be sufficient to place the endosseous implants and the superstructures

Who cannot join

Patients with any systematic disease that could complicate the surgical phase or affect osseointegration as osteoporosis and uncontrolled diabetes mellitus.
Patients with active oral infections.
Patients with history of radiotherapy in head and neck region.
Patients with poor oral hygiene.
Patients with restricted mouth openings ≤ 40mm, functional limitations, or temporo-mandibular disorders.
Heavy smokers (more than 10 cigarette / day).

Trial locations and contacts

1 site in 1 country.

Haitham Ismail, MSc contact

01282667505 ext. +2

haitham.ismail@alexu.edu.eg

Egypt1 site, 1 recruiting

Faculty of Dentistry, Alexandria University
Alexandria, 21527
Haitham Ismail, MSc, 01282667505 ext. +2, haitham.ismail@alexu.edu.eg
Recruiting

Other trials in Egypt

About this study

Official title: EVALUATION OF TWO DIFFERENT ATTACHMENT SYSTEMS IN MANDIBULAR OVERDENTURES RETAINED WITH TWO INCLINED IMPLANTS (A RANDOMIZED CONTROLLED CLINICAL TRIAL)

The aim of the study is to evaluate clinically and radiographically the Novaloc and Locator attachment systems in mandibular overdentures retained with two inclined implants.

Conditions: Inclined Implants
Being tested: Novaloc Attachment, Locator Attachment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Novaloc AttachmentOther
Each patient will receive two inclined implants placed in the mandibular canine region bilaterally using the flapless surgical technique. Patients will receive mandibular overdentures with Novaloc attachments. The proper Novaloc abutments will be selected and screwed on the implants according to the prosthetic platform and the tissue height. The metal housings will be connected to the existing mandibular overdenture by pick-up technique.
Locator AttachmentOther
Each patient will receive two inclined implants placed in the mandibular canine region bilaterally using the flapless surgical technique. Patients will receive mandibular overdentures with Locator attachments. The proper Locator abutments will be selected and screwed on the implants according to the prosthetic platform and the tissue height. The metal housings will be connected to the existing mandibular overdenture by pick-up technique.

Study groups in NCT05695612
Study group	Role	What they receive
Novaloc Attachment	Experimental	Not described Receives: Other: Novaloc Attachment
Locator attachment	Active comparator	Not described Receives: Other: Locator Attachment

What is being measured

The primary outcome is the main question the study is designed to answer.

Peri-implant Probing Depth (PD)
The distance from the gingival margin till the point of least resistance will be measured using a graduated plastic autoclavable periodontal probe. The probe will be held parallel to the long axis of the implant and introduced with light force to the peri-implant sulcus. Measurements will be made at 6 sites around each implant; mesiobuccal, mid-buccal, disto-buccal, mesio-palatal, mid-palatal and disto-palatal. Probing depth of 1 mm or less will be recorded as 1 mm, and those exceeding 1 mm, but less than 2 mm, will be recorded as 2 mm, and so on. The mean for each implant will be calculated.
Measured: up to 12 months
Modified Sulcus Bleeding Index (BI)
This will be measured using a graduated plastic autoclavable periodontal probe. The probe will be held parallel to the long axis of the implant and introduced with light force to the peri-implant sulcus. A score of 0-3 will be assigned to each labial and palatal surface of the implant then the average for each implant will be calculated according to the following criteria:
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: up to 12 months
Modified gingival index
The peri-implant mucosal tissues will be assessed according to Lobene and Weatherford as follows:
0: Absence of inflammation, normal gingiva.
1. Mild inflammation, slight color change, little change in texture of any portion of, but not entire, marginal, or papillary gingival unit (localized).
2. Mild inflammation, slight color change, little change in texture involving the entire or papillary gingival unit (generalized)..
3. Moderate inflammation, redness, and edema.
4. Severe inflammation, marked redness, edema, ulceration, and spontaneous bleeding It will be measured at 4 sites around each implant (mesially, distally, labially/ buccaly, lingually) then, the mean record will be calculated for each implant. Indices of the two implants will be added to each other, and then divided by 2 to get the mean modified gingival index for each case.
Measured: up to 12 months
Alveolar bone level
The level of alveolar bone around each implant will be assessed using CBCT(3D Accuitomo 170, 90 kVp, 5 mA, 30.8 s, 0.08 mm isotropic voxel size, J Morita, Kyoto, Japan) and the field of view will be the lower anterior sextant. The vertical bone change (distance from the implant platform to the first bone-to-implant contact, in mm) around each implant will be assessed at the buccal, lingual, mesial and distal aspects then the mean will be calculated.
Measured: up to 12 months
Implant stability
Magnetic Resonance Frequency Analyser will be used to measure the implant stability quotient (ISQ). The instrument measures the resonance frequency through the transducer attached to a implant fixture and display the result ISQ value on a scale of 1 to 100 with higher values indicating higher stability. The measurements will be made three times and the mean will be calculated.
Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Mar 2022Jun 2023

First posted25 Jan 2023
Study start10 Mar 2022
Primary completionJun 2023 (estimated)
Study completionJun 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Inclined ImplantsStudies of the same condition, open and under way.
More trials run by Alexandria 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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 22 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05695612
Sponsor's protocol ID: IRB00010556-IORG0008839
Status last verified: Jan 2023
First submitted: 13 Jan 2023
Last updated: 25 Jan 2023
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 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: EVALUATION OF TWO DIFFERENT ATTACHMENT SYSTEMS IN MANDIBULAR OVERDENTURES RETAINED WITH TWO INCLINED IMPLANTS (A RANDOMIZED CONTROLLED CLINICAL TRIAL)
ClinicalTrials.gov ID: NCT05695612
Acronym / sponsor ID: IRB00010556-IORG0008839
Conditions: Inclined Implants
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 22 participants (estimated)
Lead sponsor: Alexandria UniversityUniversity, hospital or other
Study start: 10 Mar 2022 (actual)
Primary completion: Jun 2023 (estimated)
Study completion: Jun 2023 (estimated)
First posted: 25 Jan 2023 (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.

The aim of the study is to evaluate clinically and radiographically the Novaloc and Locator attachment systems in mandibular overdentures retained with two inclined implants.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Novaloc Attachment	Experimental	Other: Novaloc Attachment
Locator attachment	Active comparator	Other: Locator Attachment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients should be completely edentulous.
Patients should have enough bone for the placement of implants at least 3.5 mm in diameter and 10.0 mm in length.
Patients should be co-operative and have adequate dexterity for placement and removal of the implant -retained overdenture.
The inter-ridge space should be sufficient to place the endosseous implants and the superstructures

Key exclusion criteria (6 listed)

Patients with any systematic disease that could complicate the surgical phase or affect osseointegration as osteoporosis and uncontrolled diabetes mellitus.
Patients with active oral infections.
Patients with history of radiotherapy in head and neck region.
Patients with poor oral hygiene.
Patients with restricted mouth openings ≤ 40mm, functional limitations, or temporo-mandibular disorders.

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
Novaloc AttachmentEach patient will receive two inclined implants placed in the mandibular canine region bilaterally using the flapless surgical technique. Patients will receive mandibular overdentures with Novaloc attachments. The proper Novaloc abutments will be selected and screwed on the implants according to the prosthetic platform and the tissue height. The metal housings will be connected to the existing mandibular overdenture by pick-up technique.	Other	Novaloc Attachment
Locator AttachmentEach patient will receive two inclined implants placed in the mandibular canine region bilaterally using the flapless surgical technique. Patients will receive mandibular overdentures with Locator attachments. The proper Locator abutments will be selected and screwed on the implants according to the prosthetic platform and the tissue height. The metal housings will be connected to the existing mandibular overdenture by pick-up technique.	Other	Locator attachment

Primary outcome

Peri-implant Probing Depth (PD)
Time frame: up to 12 months
The distance from the gingival margin till the point of least resistance will be measured using a graduated plastic autoclavable periodontal probe. The probe will be held parallel to the long axis of the implant and introduced with light force to the peri-implant sulcus. Measurements will be made at 6 sites around each implant; mesiobuccal, mid-buccal, disto-buccal, mesio-palatal, mid-palatal and disto-palatal. Probing depth of 1 mm or less will be recorded as 1 mm, and those exceeding 1 mm, but less than 2 mm, will be recorded as 2 mm, and so on. The mean for each implant will be calculated.
Modified Sulcus Bleeding Index (BI)
Time frame: up to 12 months
This will be measured using a graduated plastic autoclavable periodontal probe. The probe will be held parallel to the long axis of the implant and introduced with light force to the peri-implant sulcus. A score of 0-3 will be assigned to each labial and palatal surface of the implant then the average for each implant will be calculated according to the following criteria: 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
Modified gingival index
Time frame: up to 12 months
The peri-implant mucosal tissues will be assessed according to Lobene and Weatherford as follows: 0: Absence of inflammation, normal gingiva. 1. Mild inflammation, slight color change, little change in texture of any portion of, but not entire, marginal, or papillary gingival unit (localized). 2. Mild inflammation, slight color change, little change in texture involving the entire or papillary gingival unit (generalized).. 3. Moderate inflammation, redness, and edema. 4. Severe inflammation, marked redness, edema, ulceration, and spontaneous bleeding It will be measured at 4 sites around each implant (mesially, distally, labially/ buccaly, lingually) then, the mean record will be calculated for each implant. Indices of the two implants will be added to each other, and then divided by 2 to get the mean modified gingival index for each case.
Alveolar bone level
Time frame: up to 12 months
The level of alveolar bone around each implant will be assessed using CBCT(3D Accuitomo 170, 90 kVp, 5 mA, 30.8 s, 0.08 mm isotropic voxel size, J Morita, Kyoto, Japan) and the field of view will be the lower anterior sextant. The vertical bone change (distance from the implant platform to the first bone-to-implant contact, in mm) around each implant will be assessed at the buccal, lingual, mesial and distal aspects then the mean will be calculated.
Implant stability
Time frame: up to 12 months
Magnetic Resonance Frequency Analyser will be used to measure the implant stability quotient (ISQ). The instrument measures the resonance frequency through the transducer attached to a implant fixture and display the result ISQ value on a scale of 1 to 100 with higher values indicating higher stability. The measurements will be made three times and the mean will be calculated.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.

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.

Haitham Ismail, MSc contact

01282667505 ext. +2

haitham.ismail@alexu.edu.eg

Haitham Ismail, MSc principal investigator

Alexandria University

Ahmed Al-Shimy, PhD study director

Alexandria University

Tarek S Abdelazim, PhD study chair

Alexandria 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 Novaloc Attachment and Locator Attachment in people with Inclined Implants, run by Alexandria 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 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 25 Jan 2023. 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 Haitham Ismail, MSc (01282667505 ext. +2, haitham.ismail@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peri-implant Probing Depth (PD) (time frame: up to 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05695612.

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 25 Jan 2023.