Partial Edentulism Class 1NCT05198687
Different Treatment Modalities for Atrophied Distal Extension Maxillary Ridges
A study testing Long implant and partial overdentures, Sinus lift and long implant and short implant without sinus lift in people with Partial Edentulism Class 1, run by Mansoura University at 1 site in Egypt.
Trial summary
This study will compare clinical and radiographic outcomes of three different treatment modalities for atrophied distal extension maxillary ridges these modalities include 1. Implant retained distal extension RPD 2. Sinus lift and long implant and screw-retained prosthesis 3. Short implant and screw-retained prosthesis Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Partial Edentulism Class 1
- What is being tested?
- Long implant and partial overdentures, Sinus lift and long implant and short implant without sinus lift
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to 1 Jun 2022
- 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
- The patients will be selected according to the following:
- They have distal extension maxillary ridge with sinus pneumatization and remaining alveolar bone height 6- 8mm as verified by preoperative CBCT, have no previous denture experience. They are healthy, free from any systemic diseases relating to the bone resorption (diabetes - hyperparathyroidism). This can be achieved through medical history and clinical examination by a physician and laboratory investigations.
- Posterior maxillary alveolar ridge deficient in height, width and covered with healthy firm mucosa.
- Patients are less satisfied with conventional RPD.
- Absence of maxillary sinus diseases.
Who cannot join
- Acute or chronic sinus pathology
- History of a sinus augmentation in the past in the relevant sinus
- Poor dental hygiene. Smoker.
- Compromised general health (uncontrolled diabetes, bleeding disorder
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University
Al Mansurah, Eldakahlia, 35516
About this study
Official title: Comparison Between Three Different Treatment Modalities for Atrophied Distal Extension Maxillary Ridges Clinical and Radiographic Study
This study will compare clinical and radiographic outcomes of three different treatment modalities for atrophied distal extension maxillary ridges these modalities include
- Implant retained distal extension RPD
- Sinus lift and long implant and screw-retained prosthesis
- Short implant and screw-retained prosthesis
Read the detailed description
Patient selection:
For this study, 60 patients were selected from the clinic of Prosthodontic Department, Faculty of Dentistry, Mansoura University.
Inclusion criteria:
The patients will be selected according to the following:
- They have distal extension maxillary ridge with sinus pneumatization and remaining alveolar bone height 6- 8mm as verified by preoperative CBCT, have no previous denture experience. They are healthy, free from any systemic diseases relating to the bone resorption (diabetes - hyperparathyroidism). This can be achieved through medical history and clinical examination by a physician and laboratory investigations.
- Posterior maxillary alveolar ridge deficient in height, width and covered with healthy firm mucosa.
- Patients are less satisfied with conventional RPD.
- Absence of maxillary sinus diseases. Exclusion criteria
Patients were not eligible for this work if any of the following criteria were met:
- Acute or chronic sinus pathology
- History of a sinus augmentation in the past in the relevant sinus
- Poor dental hygiene. Smoker.
- Compromised general health (uncontrolled diabetes, bleeding disorder….). All patient were informed about all procedures that will be done and they sign the written consent form of ethical committee in faculty of dentistry Mansoura university.
Three treatment groups will be classified randomly, as follow:
- Group A: patients received two implant in premolar area mesial to maxillary sinus and used to retain partial overdenture
- Group B: patient underwent sinus lift and receive screw retained prosthesis on long implant
- Group C: patients received short implants in premolar area mesial to maxillary sinus and received screw retained prothesis All implants were inserted using computer guided implant surgery and conventional loading protocol was used.
Evaluation methods Clinical and radiographic evaluation
- Modified Plaque index. Assessment of plaque accumulation with a modified plaque index (mPI): Score 0: No detection of plaque, Score 1: Plaque only recognized by running a probe across the smooth marginal surface of the implant, Score 2 Plaque can be seen by a naked eye, Score 3 Abundance of soft matter.
- Gingival index. Assessment of bleeding tendency with a modified sulcus bleeding index (mBI): Score 0 No bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant. Score 1 Isolated bleeding spot visible, Score 2 Blood forms a confluent red line on margin, Score 3 Heavy or profuse bleeding.
- Attachment level. Distance from the junction implant/crown to the most apically probeable portion, in millimeters.
- Pocket depth. Distance between the gingival margin and the most apically probable portion, in millimeters Assessed by insertion of a standard periodontal probe with a point diameter of 0.5 mm using a probing force of 0.5 N.
- Implant stability quotient. Using resonance frequency analysis b- Radiographic evaluation will be performed in terms of: Vertical bone loss (VBL) will be evaluated as follows: The distance between implant plate form and first bone to implant contact (DIM) will be evaluated at T0, T6 and T12. VBL will be calculated by subtracting DIM at T6 and T12 from DIM at T0.
- Conditions
- Partial Edentulism Class 1
- Being tested
- Long implant and partial overdentures, Sinus lift and long implant, short implant without sinus lift, Partial overdentures, Metal ceramic prosthesis on long implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long implant and partial overdenturesProcedure or surgery
insertion of long implants anterior to the maxillary sinus to retain partial overdentures
Sinus lift and long implantProcedure or surgery
performing sinus lift surgical procedure with simultaneous placement of long implants to support screw-retained prosthesis
short implant without sinus liftProcedure or surgery
placement of short implants in the remaining bone above maxillary sinus to support screw-retained prosthesis without performing sinus lift
Partial overdenturesDevice
Distal extension metallic partial dentures retained by attachments to the implants
Metal ceramic prosthesis on long implantsDevice
porcelain fused to metal fixed screw-retained prosthesis supported by long implants
Metal ceramic prosthesis on short implantsDevice
porcelain fused to metal fixed screw-retained prosthesis supported by short implants
| Study group | Role | What they receive |
|---|---|---|
| overdentures | Active comparator | implant overdentures Receives: Procedure: Long implant and partial overdentures; Device: Partial overdentures |
| sinus lift | Active comparator | sinus lift and long implants and screw-retained prosthesis Receives: Procedure: Sinus lift and long implant; Device: Metal ceramic prosthesis on long implants |
| short implants | Active comparator | short implants and screw-retained prosthesis Receives: Procedure: short implant without sinus lift; Device: Metal ceramic prosthesis on short implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index
measuring plaque accumulation around implants using scores
Measured: one year
Gingival index
measuring gingival inflammation around implants using scores
Measured: one year
Probing depth
measuring peri-implant probing depth in mm
Measured: one year
implant stability
measuring the mobility of the implants using resonance frequency analysis Implant stability quotient)
Measured: one year
Marginal bone loss
measuring crestal bone loss around implants in mm
Measured: one year
Patient satisfaction using VAS questionnaire (visual analogue scale)
Regarding VAS, participants were asked to score their answer according to the amount of satisfaction on a 100mm line (Score zero = no satisfaction at all and score 100 = complete satisfaction). The questions cover several items related to prosthesis such as: retention, stability, comfort, ease of cleaning, ease of speaking, ease of chewing, limited activities due to embarrassment, quality of bolus and appearance.
Measured: one year
Secondary outcomes (3)
Prosthetic Aspects
measuring the incidence of prosthetic aspects and maintenance requirements
Measured: one year
Muscle activity
measure muscles activity in amplitude using electromyographs
Measured: one year
maximum bite force
measuring maximum bite force in newton using bite force transducers
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Mar 2020
- Primary completion1 May 2021
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Edentulism Class 1Studies of the same condition, open and under way.
- More trials run by Mansoura 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198687
- Sponsor's protocol ID
- M06030320
- Status last verified
- Sep 2021
- First submitted
- 24 Sep 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Three Different Treatment Modalities for Atrophied Distal Extension Maxillary Ridges Clinical and Radiographic Study
- ClinicalTrials.gov ID
- NCT05198687
- Acronym / sponsor ID
- M06030320
- Conditions
- Partial Edentulism Class 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 20 Jan 2022 (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 will compare clinical and radiographic outcomes of three different treatment modalities for atrophied distal extension maxillary ridges these modalities include
- Implant retained distal extension RPD
- Sinus lift and long implant and screw-retained prosthesis
- Short implant and screw-retained prosthesis
Detailed description
Patient selection:
For this study, 60 patients were selected from the clinic of Prosthodontic Department, Faculty of Dentistry, Mansoura University.
Inclusion criteria:
The patients will be selected according to the following:
- They have distal extension maxillary ridge with sinus pneumatization and remaining alveolar bone height 6- 8mm as verified by preoperative CBCT, have no previous denture experience. They are healthy, free from any systemic diseases relating to the bone resorption (diabetes - hyperparathyroidism). This can be achieved through medical history and clinical examination by a physician and laboratory investigations.
- Posterior maxillary alveolar ridge deficient in height, width and covered with healthy firm mucosa.
- Patients are less satisfied with conventional RPD.
- Absence of maxillary sinus diseases. Exclusion criteria
Patients were not eligible for this work if any of the following criteria were met:
- Acute or chronic sinus pathology
- History of a sinus augmentation in the past in the relevant sinus
- Poor dental hygiene. Smoker.
- Compromised general health (uncontrolled diabetes, bleeding disorder….). All patient were informed about all procedures that will be done and they sign the written consent form of ethical committee in faculty of dentistry Mansoura university.
Three treatment groups will be classified randomly, as follow:
- Group A: patients received two implant in premolar area mesial to maxillary sinus and used to retain partial overdenture
- Group B: patient underwent sinus lift and receive screw retained prosthesis on long implant
- Group C: patients received short implants in premolar area mesial to maxillary sinus and received screw retained prothesis All implants were inserted using computer guided implant surgery and conventional loading protocol was used.
Evaluation methods Clinical and radiographic evaluation
- Modified Plaque index. Assessment of plaque accumulation with a modified plaque index (mPI): Score 0: No detection of plaque, Score 1: Plaque only recognized by running a probe across the smooth marginal surface of the implant, Score 2 Plaque can be seen by a naked eye, Score 3 Abundance of soft matter.
- Gingival index. Assessment of bleeding tendency with a modified sulcus bleeding index (mBI): Score 0 No bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant. Score 1 Isolated bleeding spot visible, Score 2 Blood forms a confluent red line on margin, Score 3 Heavy or profuse bleeding.
- Attachment level. Distance from the junction implant/crown to the most apically probeable portion, in millimeters.
- Pocket depth. Distance between the gingival margin and the most apically probable portion, in millimeters Assessed by insertion of a standard periodontal probe with a point diameter of 0.5 mm using a probing force of 0.5 N.
- Implant stability quotient. Using resonance frequency analysis b- Radiographic evaluation will be performed in terms of: Vertical bone loss (VBL) will be evaluated as follows: The distance between implant plate form and first bone to implant contact (DIM) will be evaluated at T0, T6 and T12. VBL will be calculated by subtracting DIM at T6 and T12 from DIM at T0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| overdentures | Active comparator | Procedure: Long implant and partial overdentures, Device: Partial overdenturesimplant overdentures |
| sinus lift | Active comparator | Procedure: Sinus lift and long implant, Device: Metal ceramic prosthesis on long implantssinus lift and long implants and screw-retained prosthesis |
| short implants | Active comparator | Procedure: short implant without sinus lift, Device: Metal ceramic prosthesis on short implantsshort implants and screw-retained prosthesis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- They have distal extension maxillary ridge with sinus pneumatization and remaining alveolar bone height 6- 8mm as verified by preoperative CBCT, have no previous denture experience. They are healthy, free from any systemic diseases relating to the bone resorption (diabetes - hyperparathyroidism). This can be achieved through medical history and clinical examination by a physician and laboratory investigations.
- Posterior maxillary alveolar ridge deficient in height, width and covered with healthy firm mucosa.
- Patients are less satisfied with conventional RPD.
- Absence of maxillary sinus diseases.
Key exclusion criteria (4 listed)
- Acute or chronic sinus pathology
- History of a sinus augmentation in the past in the relevant sinus
- Poor dental hygiene. Smoker.
- Compromised general health (uncontrolled diabetes, bleeding disorder
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 |
|---|---|---|
| Long implant and partial overdenturesinsertion of long implants anterior to the maxillary sinus to retain partial overdentures | Procedure or surgery | overdentures |
| Sinus lift and long implantperforming sinus lift surgical procedure with simultaneous placement of long implants to support screw-retained prosthesis | Procedure or surgery | sinus lift |
| short implant without sinus liftplacement of short implants in the remaining bone above maxillary sinus to support screw-retained prosthesis without performing sinus lift | Procedure or surgery | short implants |
| Partial overdenturesDistal extension metallic partial dentures retained by attachments to the implants | Device | overdentures |
| Metal ceramic prosthesis on long implantsporcelain fused to metal fixed screw-retained prosthesis supported by long implants | Device | sinus lift |
| Metal ceramic prosthesis on short implantsporcelain fused to metal fixed screw-retained prosthesis supported by short implants | Device | short implants |
Primary outcome
Plaque index
Time frame: one year
measuring plaque accumulation around implants using scores
Gingival index
Time frame: one year
measuring gingival inflammation around implants using scores
Probing depth
Time frame: one year
measuring peri-implant probing depth in mm
implant stability
Time frame: one year
measuring the mobility of the implants using resonance frequency analysis Implant stability quotient)
Marginal bone loss
Time frame: one year
measuring crestal bone loss around implants in mm
Patient satisfaction using VAS questionnaire (visual analogue scale)
Time frame: one year
Regarding VAS, participants were asked to score their answer according to the amount of satisfaction on a 100mm line (Score zero = no satisfaction at all and score 100 = complete satisfaction). The questions cover several items related to prosthesis such as: retention, stability, comfort, ease of cleaning, ease of speaking, ease of chewing, limited activities due to embarrassment, quality of bolus and appearance.
3 secondary outcomes
Prosthetic Aspects
Time frame: one year
Muscle activity
Time frame: one year
maximum bite force
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long implant and partial overdentures, Sinus lift and long implant and short implant without sinus lift in people with Partial Edentulism Class 1, run by Mansoura 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 5 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: status not confirmed, as of the sponsor's last update on 2 Mar 2022. 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?
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?
Plaque index (time frame: one year). The study lists 6 primary outcomes in all. 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 2 Mar 2022.