Peri-Implant TissuesNCT06647199
Evaluation of Peri-Implant Tissues of Different Implant Assisted Overdentures
A study testing the plaque index (PI), the bleeding index (BI) and simplified gingival index(GI), in people with Peri-Implant Tissues, run by Mansoura University at 1 site in Egypt.
Trial summary
The researchers will perform a parallel randomized, clinical trial involving completely edentulous healthy patients. Each participant will receive four dental implants in the anterior mandible. According to the processing technique and denture base material, the patients will be classified into three groups. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Peri-Implant Tissues
- What is being tested?
- the plaque index (PI), the bleeding index (BI) and simplified gingival index(GI),
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 22 Jul 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Each selected subject fulfilled the following criteria:
- all subjects complained about insufficient retention and stability pertained to their mandibular dentures at their presentation;
- they had enough quantity and quality of bone in the mandibular lateral and canine areas to support the standard implants (14 mm in length and 3.6 mm in diameter) as verified by CBCT;
- they had healthy keratinized mucosa and a class I maxillomandibular relationship; besides, they had enough interarch space.
Who cannot join
- Diabetes, osteoporosis, and immunological deficiency
- subjects having head and neck radiation therapy or using anticoagulant medication.
- Those who had a history of temporomandibular joint dysfunction, which could interfere with appropriate function,
- those who smoked heavily were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Peri-Implant Tissues of CAD/CAM Milled PEEK, PMMA and Conventional Implant Assisted Overdentures
The researchers will perform a parallel randomized, clinical trial involving completely edentulous healthy patients. Each participant will receive four dental implants in the anterior mandible. According to the processing technique and denture base material, the patients will be classified into three groups. Group I: involves CAD/CAM milled poly ether ether ketone PEEK overdentures, Group II: involves CAD/CAM milled PMMA overdentures and Group III :involves conventional heat-cured poly methyl methacrylate PMMA overdentures. All assessments were carried out at delivery, 6 moths and one year after overdenture insertion to clinically evaluate the preiimplant tissues. .
Read the detailed description
The study will be conducted to compare three different mandibular implant- assisted complete overdentures. These overdentures were constructed from three different materials and techniques: CAD/CAM-milled poly ether ether ketone (CAD/CAM PEEK MOD), CAD/CAM-milled poly methyl methacrylate (CAD/CAM PMMA MOD), and conventional heat-cured poly methyl methacrylate (conventional PMMA MOD) to clinically evaluate the preiimplant tissues.
The participants enrolled in the current study were randomly assigned to one of three groups based on the material and technique of their mandibular overdenture bases. All participants were delivered new sets of conventional complete dentures implied bilateral balanced occlusal scheme. They were well instructed to wear their dentures regularly for 3 months prior to implant installment ascribed to enhancement of the neuromuscular adaptation. For each patient, the mandibular denture was duplicated with clear auto- polymerizing acrylic resin to fabricate the mandibular surgical template with gutta percha markers. By employing CBCT, all patients were scanned conforming to the dual scan protocol .The implants were installed virtually parallel to each other and perpendicular to the occlusal plane at the areas of canines and lateral incisors .This was carried out using 3D image planning software . The surgical stent with four sleeves was constructed by rapid prototyping .It was placed over the proposed implant locations.Four dental implants were surgically placed in the anterior region of the mandible.Three months afterward, the mandibular impression was registered. The primary impression was recorded and poured to gain the primary cast. Upon that primary cast, a closed custom tray was constructed. The positioner attachments were screwed to the implants, the processing caps and metal housings were secured over them. The custom tray was border molded. By using silicon impression material , the definitive impression was made at the abutment level. The processing caps and the metal housings were removed from the impression which was being poured by extra hard scannable dental stone to obtain the master cast. Maxillomandibular relations were registered .This was accomplished with mandibular conventional record blocks opposed by the existing maxillary complete denture. Semi anatomical acrylic teeth were arranged employing bilateral balanced occlusion .The waxed overdentures were tried in the patient's mouth. According to the mandibular denture base material and processing technique of the prostheses, the subjects were divided into three groups: The first group (I) included 10 participants whose mandibular overdentures were fabricated by milling pre-polymerized poly ether ether ketone PEEK discs (CAD/CAM PEEK MODs, the second group(II) included 10 participants whose mandibular overdentures were constructed by milling prepolymerised PMMA resin discs (CAD/CAM PMMA MODs), while the third group(III) included 10 participants received conventionally constructed heat-cured poly methyl methacrylate mandibular PMMA overdentures (conventional PMMA MOD).All needed adjustments were executed at the insertion visit. This is to assure appropriate border extension, proper denture base fit, even occlusal contact besides patient comfort. The female housing attachment was picked up to the fitting surface of the mandibular overdenture bases using self-cure acrylic resin. The white processing cap was removed and replaced by a blue one. The mandibular overdentures were delivered to all participants according to their group.
Patients' evaluation Clinical evaluation Peri-implant soft tissue changes as regards plaque, bleeding, and gingival scores were assessed employing the modified plaque index (PI), bleeding index (BI) and simplified gingival index (GI), respectively. These indices were evaluated at prosthesis insertion (T0), 3 months (T1) , 6 months(T3) and 12 month (T4) after insertion. A calibrated pressure-sensitive plastic periodontal probe was utilized.
- Conditions
- Peri-Implant Tissues
- Being tested
- the plaque index (PI), the bleeding index (BI), simplified gingival index(GI),
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the plaque index (PI)Procedure or surgery
Peri-implant soft tissue changes as regards plaque was assessed employing the modified plaque index (PI). Patients were evaluated clinically at the time of mandibular overdenture insertion (T0), 6 months (T1), 12 months (T2) and 3 years (T3) after denture insertion. Both plaque index (PI) and bleeding index (BI) were evaluated according to the Mombelli index , and gingival index (GI) according to the modified Silness and Loe index. Measurements were taken from the buccal, lingual, mesial, and distal aspects of each implant. All the clinical parameters were measured from the four aspects using a graduated periodontal probe (Hawe Perio-Probe, Kerr), and the sum total of the four readings was divided by four to obtain the mean value. The distance between the marginal border of the peri-implant mucosa and the tip of the probe was measured and considered as pocket depth (PD).
the bleeding index (BI)Procedure or surgery
Peri-implant tissue changes as bleeding score was assessed employing the bleeding index (BI) . Patients were evaluated clinically at the time of mandibular overdenture insertion (T0), 6 months (T1), 12 months (T2) and 3 years (T3) after denture insertion. Both plaque index (PI) and bleeding index (BI) were evaluated according to the Mombelli index , and gingival index (GI) according to the modified Silness and Loe index. Measurements were taken from the buccal, lingual, mesial, and distal aspects of each implant. All the clinical parameters were measured from the four aspects using a graduated periodontal probe (Hawe Perio-Probe, Kerr), and the sum total of the four readings was divided by four to obtain the mean value. The distance between the marginal border of the peri-implant mucosa and the tip of the probe was measured and considered as pocket depth (PD).
simplified gingival index(GI),Procedure or surgery
Peri-implant soft tissue changes as regards gingival scores was assessed simplified gingival index(GI). Patients were evaluated clinically at the time of mandibular overdenture insertion (T0), 6 months (T1), 12 months (T2) and 3 years (T3) after denture insertion. Both plaque index (PI) and bleeding index (BI) were evaluated according to the Mombelli index , and gingival index (GI) according to the modified Silness and Loe index. Measurements were taken from the buccal, lingual, mesial, and distal aspects of each implant. All the clinical parameters were measured from the four aspects using a graduated periodontal probe (Hawe Perio-Probe, Kerr), and the sum total of the four readings was divided by four to obtain the mean value. The distance between the marginal border of the peri-implant mucosa and the tip of the probe was measured and considered as pocket depth (PD
| Study group | Role | What they receive |
|---|---|---|
| CAD/CAM Milled PEEK | Experimental | In the first group (CAD/CAM PEEK MODs), the mandibular master cast, mandibular trial denture, and maxillary denture were scanned using an intraoral digital scanner both separately while biting. The scanned data were saved in standard tessellation language (STL) file format and entered into the design software . The mandibular denture base and set-up were virtually designed. Based on the virtually created mandibular denture bases, the STL file of the designed denture base was imported into the milling machine to mill the prepolymerised PEEK discs to construct the CAD/CAM PEEK MOD base . Receives: Procedure: the plaque index (PI); Procedure: the bleeding index (BI); Procedure: simplified gingival index(GI), |
| CAD/CAM milled PMMA | Experimental | In the second group (CAD/CAM PMMA MODs), the STL file of the designed denture base was imported into the milling machine to mill the PMMA MOD base. The mandibular denture base and set-up were virtually designed. Based on the virtually created mandibular denture bases, the CAD/CAM PMMA MOD base was milled .Based on the scanned denture teeth, denture teeth were milled from tooth-coloured prepolymerized PMMA blocks, finished and polished, and then bonded with a methacrylate-based bonding agent into the PMMA milled base. Receives: Procedure: the plaque index (PI); Procedure: the bleeding index (BI); Procedure: simplified gingival index(GI), |
| conventional PMMA MOD | Experimental | the traditional heat-cured PMMA MOD was constructed. The waxed-up overdenture was processed in heat-cured PMMA resin using the compression mould technique. Receives: Procedure: the plaque index (PI); Procedure: the bleeding index (BI); Procedure: simplified gingival index(GI), |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-Implant Tissues changes regarding plaque index (PI).
Peri-implant soft tissue changes as regards plaque was assessed employing the modified plaque index (PI).
Measured: 2 years
Peri-Implant Tissues changes regarding The bleeding index (BI).
The bleeding index in accordance with Mombelli et al was used: score 0: no bleeding when using a periodontal probe; score1: isolated bleeding spots visible; score 2: a confluent red line of blood along the mucosal margin; score 3: heavy or profuse bleeding.
Measured: 2 years
Peri-Implant Tissues changes regarding The gingival index (GI)
The modified Silness and Loe index, was used to calculate the gingival index:
Score 0: normal peri implant mucosa; score 1: mild inflammation, slight color change, and slight edoema; score 2: moderate inflammation, redness, edoema, and glazing; and score 3: severe inflammation, marked redness and edoema, and ulceration.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Dec 2020
- Primary completion20 Jan 2022
- Study completion22 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-Implant TissuesStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Ahmad El Waseef, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647199
- Sponsor's protocol ID
- Mansoura
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Authors will share individual participant data if needed upon publishing process
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Peri-Implant Tissues of CAD/CAM Milled PEEK, PMMA and Conventional Implant Assisted Overdentures
- ClinicalTrials.gov ID
- NCT06647199
- Acronym / sponsor ID
- Mansoura
- Conditions
- Peri-Implant Tissues
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 22 Jul 2023 (actual)
- First posted
- 17 Oct 2024 (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 researchers will perform a parallel randomized, clinical trial involving completely edentulous healthy patients. Each participant will receive four dental implants in the anterior mandible. According to the processing technique and denture base material, the patients will be classified into three groups. Group I: involves CAD/CAM milled poly ether ether ketone PEEK overdentures, Group II: involves CAD/CAM milled PMMA overdentures and Group III :involves conventional heat-cured poly methyl methacrylate PMMA overdentures. All assessments were carried out at delivery, 6 moths and one year after overdenture insertion to clinically evaluate the preiimplant tissues. .
Detailed description
The study will be conducted to compare three different mandibular implant- assisted complete overdentures. These overdentures were constructed from three different materials and techniques: CAD/CAM-milled poly ether ether ketone (CAD/CAM PEEK MOD), CAD/CAM-milled poly methyl methacrylate (CAD/CAM PMMA MOD), and conventional heat-cured poly methyl methacrylate (conventional PMMA MOD) to clinically evaluate the preiimplant tissues.
The participants enrolled in the current study were randomly assigned to one of three groups based on the material and technique of their mandibular overdenture bases. All participants were delivered new sets of conventional complete dentures implied bilateral balanced occlusal scheme. They were well instructed to wear their dentures regularly for 3 months prior to implant installment ascribed to enhancement of the neuromuscular adaptation. For each patient, the mandibular denture was duplicated with clear auto- polymerizing acrylic resin to fabricate the mandibular surgical template with gutta percha markers. By employing CBCT, all patients were scanned conforming to the dual scan protocol .The implants were installed virtually parallel to each other and perpendicular to the occlusal plane at the areas of canines and lateral incisors .This was carried out using 3D image planning software . The surgical stent with four sleeves was constructed by rapid prototyping .It was placed over the proposed implant locations.Four dental implants were surgically placed in the anterior region of the mandible.Three months afterward, the mandibular impression was registered. The primary impression was recorded and poured to gain the primary cast. Upon that primary cast, a closed custom tray was constructed. The positioner attachments were screwed to the implants, the processing caps and metal housings were secured over them. The custom tray was border molded. By using silicon impression material , the definitive impression was made at the abutment level. The processing caps and the metal housings were removed from the impression which was being poured by extra hard scannable dental stone to obtain the master cast. Maxillomandibular relations were registered .This was accomplished with mandibular conventional record blocks opposed by the existing maxillary complete denture. Semi anatomical acrylic teeth were arranged employing bilateral balanced occlusion .The waxed overdentures were tried in the patient's mouth. According to the mandibular denture base material and processing technique of the prostheses, the subjects were divided into three groups: The first group (I) included 10 participants whose mandibular overdentures were fabricated by milling pre-polymerized poly ether ether ketone PEEK discs (CAD/CAM PEEK MODs, the second group(II) included 10 participants whose mandibular overdentures were constructed by milling prepolymerised PMMA resin discs (CAD/CAM PMMA MODs), while the third group(III) included 10 participants received conventionally constructed heat-cured poly methyl methacrylate mandibular PMMA overdentures (conventional PMMA MOD).All needed adjustments were executed at the insertion visit. This is to assure appropriate border extension, proper denture base fit, even occlusal contact besides patient comfort. The female housing attachment was picked up to the fitting surface of the mandibular overdenture bases using self-cure acrylic resin. The white processing cap was removed and replaced by a blue one. The mandibular overdentures were delivered to all participants according to their group.
Patients' evaluation Clinical evaluation Peri-implant soft tissue changes as regards plaque, bleeding, and gingival scores were assessed employing the modified plaque index (PI), bleeding index (BI) and simplified gingival index (GI), respectively. These indices were evaluated at prosthesis insertion (T0), 3 months (T1) , 6 months(T3) and 12 month (T4) after insertion. A calibrated pressure-sensitive plastic periodontal probe was utilized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM Milled PEEK | Experimental | Procedure: the plaque index (PI), Procedure: the bleeding index (BI), Procedure: simplified gingival index(GI),In the first group (CAD/CAM PEEK MODs), the mandibular master cast, mandibular trial denture, and maxillary denture were scanned using an intraoral digital scanner both separately while biting. The scanned data were saved in standard tessellation language (STL) file format and entered into the design software . The mandibular denture base and set-up were virtually designed. Based on the virtually created mandibular denture bases, the STL file of the designed denture base was imported into the milling machine to mill the prepolymerised PEEK discs to construct the CAD/CAM PEEK MOD base . |
| CAD/CAM milled PMMA | Experimental | Procedure: the plaque index (PI), Procedure: the bleeding index (BI), Procedure: simplified gingival index(GI),In the second group (CAD/CAM PMMA MODs), the STL file of the designed denture base was imported into the milling machine to mill the PMMA MOD base. The mandibular denture base and set-up were virtually designed. Based on the virtually created mandibular denture bases, the CAD/CAM PMMA MOD base was milled .Based on the scanned denture teeth, denture teeth were milled from tooth-coloured prepolymerized PMMA blocks, finished and polished, and then bonded with a methacrylate-based bonding agent into the PMMA milled base. |
| conventional PMMA MOD | Experimental | Procedure: the plaque index (PI), Procedure: the bleeding index (BI), Procedure: simplified gingival index(GI),the traditional heat-cured PMMA MOD was constructed. The waxed-up overdenture was processed in heat-cured PMMA resin using the compression mould technique. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Each selected subject fulfilled the following criteria:
- all subjects complained about insufficient retention and stability pertained to their mandibular dentures at their presentation;
- they had enough quantity and quality of bone in the mandibular lateral and canine areas to support the standard implants (14 mm in length and 3.6 mm in diameter) as verified by CBCT;
- they had healthy keratinized mucosa and a class I maxillomandibular relationship; besides, they had enough interarch space.
Key exclusion criteria (4 listed)
- Diabetes, osteoporosis, and immunological deficiency
- subjects having head and neck radiation therapy or using anticoagulant medication.
- Those who had a history of temporomandibular joint dysfunction, which could interfere with appropriate function,
- those who smoked heavily were also excluded.
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 |
|---|---|---|
| the plaque index (PI)Peri-implant soft tissue changes as regards plaque was assessed employing the modified plaque index (PI). Patients were evaluated clinically at the time of mandibular overdenture insertion (T0), 6 months (T1), 12 months (T2) and 3 years (T3) after denture insertion. Both plaque index (PI) and bleeding index (BI) were evaluated according to the Mombelli index , and gingival index (GI) according to the modified Silness and Loe index. Measurements were taken from the buccal, lingual, mesial, and distal aspects of each implant. All the clinical parameters were measured from the four aspects using a graduated periodontal probe (Hawe Perio-Probe, Kerr), and the sum total of the four readings was divided by four to obtain the mean value. The distance between the marginal border of the peri-implant mucosa and the tip of the probe was measured and considered as pocket depth (PD). | Procedure or surgery | CAD/CAM Milled PEEK, CAD/CAM milled PMMA, conventional PMMA MOD |
| the bleeding index (BI)Peri-implant tissue changes as bleeding score was assessed employing the bleeding index (BI) . Patients were evaluated clinically at the time of mandibular overdenture insertion (T0), 6 months (T1), 12 months (T2) and 3 years (T3) after denture insertion. Both plaque index (PI) and bleeding index (BI) were evaluated according to the Mombelli index , and gingival index (GI) according to the modified Silness and Loe index. Measurements were taken from the buccal, lingual, mesial, and distal aspects of each implant. All the clinical parameters were measured from the four aspects using a graduated periodontal probe (Hawe Perio-Probe, Kerr), and the sum total of the four readings was divided by four to obtain the mean value. The distance between the marginal border of the peri-implant mucosa and the tip of the probe was measured and considered as pocket depth (PD). | Procedure or surgery | CAD/CAM Milled PEEK, CAD/CAM milled PMMA, conventional PMMA MOD |
| simplified gingival index(GI),Peri-implant soft tissue changes as regards gingival scores was assessed simplified gingival index(GI). Patients were evaluated clinically at the time of mandibular overdenture insertion (T0), 6 months (T1), 12 months (T2) and 3 years (T3) after denture insertion. Both plaque index (PI) and bleeding index (BI) were evaluated according to the Mombelli index , and gingival index (GI) according to the modified Silness and Loe index. Measurements were taken from the buccal, lingual, mesial, and distal aspects of each implant. All the clinical parameters were measured from the four aspects using a graduated periodontal probe (Hawe Perio-Probe, Kerr), and the sum total of the four readings was divided by four to obtain the mean value. The distance between the marginal border of the peri-implant mucosa and the tip of the probe was measured and considered as pocket depth (PD | Procedure or surgery | CAD/CAM Milled PEEK, CAD/CAM milled PMMA, conventional PMMA MOD |
Primary outcome
Peri-Implant Tissues changes regarding plaque index (PI).
Time frame: 2 years
Peri-implant soft tissue changes as regards plaque was assessed employing the modified plaque index (PI).
Peri-Implant Tissues changes regarding The bleeding index (BI).
Time frame: 2 years
The bleeding index in accordance with Mombelli et al was used: score 0: no bleeding when using a periodontal probe; score1: isolated bleeding spots visible; score 2: a confluent red line of blood along the mucosal margin; score 3: heavy or profuse bleeding.
Peri-Implant Tissues changes regarding The gingival index (GI)
Time frame: 2 years
The modified Silness and Loe index, was used to calculate the gingival index: Score 0: normal peri implant mucosa; score 1: mild inflammation, slight color change, and slight edoema; score 2: moderate inflammation, redness, edoema, and glazing; and score 3: severe inflammation, marked redness and edoema, and ulceration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: Undecided. Authors will share individual participant data if needed upon publishing process
Related trials for Peri-Implant Tissues
Not yet recruiting
Effect of Customized Versus Stock Healing Abutments on Peri-Implant Soft Tissue
Peri-Implantitis
Enrolling by invitation
Peri-implant Tissue Changes Using Dual Zone Concept With Connective Tissue Graft Versus Concentrated Growth Factor
Hopeless Tooth in Esthetic Zone, Loss of Soft and Hard Tissue Around Implant
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
Active, not recruiting
Healing Outcomes of Peri-implant Soft Tissues With Different Healing Abutments
Implant
Not yet recruitingObservational study
Association Between Peri-implant Tissue Health and Crown Shape: a Prospective Study
Dental Implants
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 the plaque index (PI), the bleeding index (BI) and simplified gingival index(GI), in people with Peri-Implant Tissues, 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 4 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: finished, as of the sponsor's last update on 17 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peri-Implant Tissues changes regarding plaque index (PI). (time frame: 2 years). The study lists 3 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 17 Oct 2024.