Partial Edentulism Class 2 Due to Periodontal DiseaseNCT05646498
Management of Distally Extension Maxillary Atrophied Ridge With Two Different Minimal Invasive Treatment Modalities
A study testing Closed sinus lift procedure and Crestal sinus lift in people with Partial Edentulism Class 2 Due to Periodontal Disease, run by Mansoura University at 1 site in Egypt.
Trial summary
This study will compare clinical and radio graphic outcomes of two minimally invasive different treatment modalities for atrophied unilateral distal extension maxillary ridges these modalities include 1. Medially placed implant and Implant retained distal extension removable partial denture 2. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Partial Edentulism Class 2 Due to Periodontal Disease
- What is being tested?
- Closed sinus lift procedure and Crestal sinus lift
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Mar 2021to 22 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patients will be selected according to the following:
- They have atrophied unilateral distal extension maxillary ridge and remaining alveolar bone height 6- 8mm as verified by preoperative CBCT, 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 Mansoura, Eldakahlia, Egypt, 35516
Al Mansurah, 02050
About this study
Official title: Clinical and Patient- Satisfaction Outcomes During Management of Atrophied Unilateral Distally Extension Maxillary Ridge With Two Different Minimal Invasive Treatment Modalities. 1-year Randomized Controlled Clinical Trial.
This study will compare clinical and radio graphic outcomes of two minimally invasive different treatment modalities for atrophied unilateral distal extension maxillary ridges these modalities include
- Medially placed implant and Implant retained distal extension removable partial denture
- Sinus lift and long implant to support fixed screw-retained prosthesis
Read the detailed description
Patient selection:
For this study, 40 patients were selected from the clinic of Prosthodontics Department, Faculty of Dentistry, Mansoura University.
Inclusion criteria:
The patients will be selected according to the following:
- They have atrophied unilateral distal extension maxillary ridge and remaining alveolar bone height 6- 8 mm as verified by preoperative cone beam. 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 covering.
- Patients are less satisfied with conventional removable partial denture.
- 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 I: patients received one implant in premolar area medial to maxillary sinus and used to retain partial over-denture.
- Group II: patient underwent sinus lift and receive screw retained prosthesis on long implant All implants were inserted using computer guided and flap-less implant surgery and conventional loading protocol was used.
Evaluation methods Clinical and radio-graphic evaluation
- Modified Plaque index. Assessment of plaque accumulation with a modified plaque index : 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.
- Marginal index. Assessment of bleeding tendency with a modified bleeding index : Score 0 No bleeding when a periodontal probe is passed along the 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 probe able portion, in millimeters.
- Pocket depth. Distance between the 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- Radio-graphic evaluation will be performed in terms of:
Vertical bone loss will be evaluated as follows:
The distance between implant plate form and first bone to implant contact will be evaluated after one year.
- Being tested
- Closed sinus lift procedure, Crestal sinus lift
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed sinus lift procedureProcedure or surgery
Also called Minimal invasive sinus lift
The closed sinus lift is the elevation of the sinus membrane through the osteotomy
Crestal sinus liftDevice
Also called Minimal invasive sinus lift
The crestal approach is the elevation of the sinus membrane by osteotomes, piezosurgery, or Densah burs.
| Study group | Role | What they receive |
|---|---|---|
| implant retained removable overdentures | Active comparator | Procedure: Long implant and partial overdentures insertion of long implants anterior to the maxillary sinus to retain partial overdentures
Device: Partial overdentures Distal extension metallic partial dentures retained by attachments to the implants Receives: Procedure: Closed sinus lift procedure; Device: Crestal sinus lift |
| implant supported fixed screw retained prosthesis | Active comparator | Procedure: Sinus lift and long implant performing sinus lift surgical procedure with simultaneous placement of limplants to support screw-retained prosthesis
Device: Metal ceramic prosthesis on long implants porcelain fused to metal fixed screw-retained prosthesis supported by implants Receives: Procedure: Closed sinus lift procedure; Device: Crestal sinus lift |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index evaluation
measuring plaque accumulation around implants using scores Plaque will be assessed according to modified plaque index describe as follows: score 0; no plaque detected, score 1; plaque recognized only by running a probe across a smooth marginal surface of the implant, score 2; plaque can be seen by naked eye, and score 3; abundance of soft mater.
Measured: one year
Gingival index evaluation
measuring inflammation around implants using scores Modified index will be recorded as follows: score 0; normal , score 1; mild inflammation (slight change in color \& slight edema), but no bleeding on probing, score 2; moderate inflammation (redness \& edema), and bleeding on probing, and score 3; sever inflammation (marked redness, edema \& ulceration) with tendency to spontaneous bleeding.
Measured: one year
Probing depth evaluation
measuring per-implant probing depth in mm. Using a calibrated plastic periodontal probe, the distance between marginal border of the and the tip of the probe was measured in mm and considered as pocket depth.
Measured: one year
Implant stability evaluation
measuring the mobility of the implants using resonance frequency analysis Implant stability quotient) The resonance frequencies will be measured with the osstell® device (implant stability meter) and will be expressed with measurement scale (implant stability quotient).
Measured: one year
Radio graphic evaluation
measuring bone loss around implants in mm Radio-graphs were taken using direct digital imaging system
- Marginal alveolar bone changes (vertical and horizontal bone loss) were measured at medial and distal surface of each implant in mm.
Measured: one year
Patient satisfaction
Patient satisfaction using questionnaire (visual analogue scale) Patient satisfaction was evaluated using a questionnaire based on visual analog scale . Patients were asked to mark their answer (amount of satisfaction) on a 100-mm line (with zero refers to not satisfied at all and 100 refers to completely satisfied). The mean of the answers (length of the lines from zero to the marks in mm) for each question. 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 was subjected to statistical analysis
Measured: one year
Secondary outcomes (3)
Prosthetic complication
incidence of prosthetic aspects and maintenance requirements
Measured: one year
Muscle activity
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 posted12 Dec 2022
- Study start21 Mar 2021
- Primary completion17 Jun 2022
- Study completion22 Jun 2023 (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 2 Due to Periodontal DiseaseStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elgamal, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646498
- Sponsor's protocol ID
- A01140420
- Status last verified
- Apr 2023
- First submitted
- 17 Nov 2022
- Last updated
- 24 Apr 2023
- 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 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Patient- Satisfaction Outcomes During Management of Atrophied Unilateral Distally Extension Maxillary Ridge With Two Different Minimal Invasive Treatment Modalities. 1-year Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT05646498
- Acronym / sponsor ID
- A01140420
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 21 Mar 2021 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 22 Jun 2023 (estimated)
- First posted
- 12 Dec 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 radio graphic outcomes of two minimally invasive different treatment modalities for atrophied unilateral distal extension maxillary ridges these modalities include
- Medially placed implant and Implant retained distal extension removable partial denture
- Sinus lift and long implant to support fixed screw-retained prosthesis
Detailed description
Patient selection:
For this study, 40 patients were selected from the clinic of Prosthodontics Department, Faculty of Dentistry, Mansoura University.
Inclusion criteria:
The patients will be selected according to the following:
- They have atrophied unilateral distal extension maxillary ridge and remaining alveolar bone height 6- 8 mm as verified by preoperative cone beam. 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 covering.
- Patients are less satisfied with conventional removable partial denture.
- 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 I: patients received one implant in premolar area medial to maxillary sinus and used to retain partial over-denture.
- Group II: patient underwent sinus lift and receive screw retained prosthesis on long implant All implants were inserted using computer guided and flap-less implant surgery and conventional loading protocol was used.
Evaluation methods Clinical and radio-graphic evaluation
- Modified Plaque index. Assessment of plaque accumulation with a modified plaque index : 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.
- Marginal index. Assessment of bleeding tendency with a modified bleeding index : Score 0 No bleeding when a periodontal probe is passed along the 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 probe able portion, in millimeters.
- Pocket depth. Distance between the 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- Radio-graphic evaluation will be performed in terms of:
Vertical bone loss will be evaluated as follows:
The distance between implant plate form and first bone to implant contact will be evaluated after one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| implant retained removable overdentures | Active comparator | Procedure: Closed sinus lift procedure, Device: Crestal sinus liftProcedure: Long implant and partial overdentures insertion of long implants anterior to the maxillary sinus to retain partial overdentures Device: Partial overdentures Distal extension metallic partial dentures retained by attachments to the implants |
| implant supported fixed screw retained prosthesis | Active comparator | Procedure: Closed sinus lift procedure, Device: Crestal sinus liftProcedure: Sinus lift and long implant performing sinus lift surgical procedure with simultaneous placement of limplants to support screw-retained prosthesis Device: Metal ceramic prosthesis on long implants porcelain fused to metal fixed screw-retained prosthesis supported by implants |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patients will be selected according to the following:
Key exclusion criteria (4 listed)
- • Acute or chronic sinus pathology
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 |
|---|---|---|
| Closed sinus lift procedureAlso: Minimal invasive sinus liftThe closed sinus lift is the elevation of the sinus membrane through the osteotomy | Procedure or surgery | implant retained removable overdentures, implant supported fixed screw retained prosthesis |
| Crestal sinus liftAlso: Minimal invasive sinus liftThe crestal approach is the elevation of the sinus membrane by osteotomes, piezosurgery, or Densah burs. | Device | implant retained removable overdentures, implant supported fixed screw retained prosthesis |
Primary outcome
Plaque index evaluation
Time frame: one year
measuring plaque accumulation around implants using scores Plaque will be assessed according to modified plaque index describe as follows: score 0; no plaque detected, score 1; plaque recognized only by running a probe across a smooth marginal surface of the implant, score 2; plaque can be seen by naked eye, and score 3; abundance of soft mater.
Gingival index evaluation
Time frame: one year
measuring inflammation around implants using scores Modified index will be recorded as follows: score 0; normal , score 1; mild inflammation (slight change in color \& slight edema), but no bleeding on probing, score 2; moderate inflammation (redness \& edema), and bleeding on probing, and score 3; sever inflammation (marked redness, edema \& ulceration) with tendency to spontaneous bleeding.
Probing depth evaluation
Time frame: one year
measuring per-implant probing depth in mm. Using a calibrated plastic periodontal probe, the distance between marginal border of the and the tip of the probe was measured in mm and considered as pocket depth.
Implant stability evaluation
Time frame: one year
measuring the mobility of the implants using resonance frequency analysis Implant stability quotient) The resonance frequencies will be measured with the osstell® device (implant stability meter) and will be expressed with measurement scale (implant stability quotient).
Radio graphic evaluation
Time frame: one year
measuring bone loss around implants in mm Radio-graphs were taken using direct digital imaging system - Marginal alveolar bone changes (vertical and horizontal bone loss) were measured at medial and distal surface of each implant in mm.
Patient satisfaction
Time frame: one year
Patient satisfaction using questionnaire (visual analogue scale) Patient satisfaction was evaluated using a questionnaire based on visual analog scale . Patients were asked to mark their answer (amount of satisfaction) on a 100-mm line (with zero refers to not satisfied at all and 100 refers to completely satisfied). The mean of the answers (length of the lines from zero to the marks in mm) for each question. 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 was subjected to statistical analysis
3 secondary outcomes
Prosthetic complication
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 24 Apr 2023.
- Individual participant dataSharing planned: Yes
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 Closed sinus lift procedure and Crestal sinus lift in people with Partial Edentulism Class 2 Due to Periodontal Disease, 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 24 Apr 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?
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 evaluation (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 24 Apr 2023.