Bone Loss in JawPhase 2NCT05906563
Evaluation of Melatonin and Metformin Loaded Nanoparticles in the Treatment of Periodontal Intra-bony Defects
A Phase 2 study testing Melatonin gel, Metformin and melatonin gel and scaling and root planning in people with Bone Loss in Jaw, run by Amira ragab at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to assess the effectiveness of local delivery of melatonin and metformin loaded nanoparticle gel as adjunct to scaling and root planning (SRP) in the treatment of periodontal intra bony defect. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss in Jaw
- What is being tested?
- Melatonin gel, Metformin and melatonin gel and scaling and root planning
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Dec 2022to Jun 2024
- Phase
- Phase 2
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with at least one intra-bony defect diagnosed clinically and radiographically
Who cannot join
- Patients with systemic diseases.
- Pregnant and lactating females.
- Smokers and tobacco chewers.
- History of antibiotic and periodontal therapy in the last 3 months.
- Patients not compliant with oral hygiene procedures.
- Patients with a known or suspected allergy to the melatonin or metformin.
- Individuals on systemic drug affecting metabolic bone diseases and medically compromised patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Melatonin and Metformin Loaded Nanoparticles in the Treatment of Periodontal Intra-bony Defects: A Randomized Controlled Clinical Trial
The goal of this clinical trial is to assess the effectiveness of local delivery of melatonin and metformin loaded nanoparticle gel as adjunct to scaling and root planning (SRP) in the treatment of periodontal intra bony defect.
fifty two healthy patients(n=52) with at least one periodontal intra-bony defect will be included in the study, all selected patients will be motivated about the benefit of plaque control and periodontal treatment . The participant will be selected from outpatient clinic of the Department of Oral Medicine and Periodontology , Faculty of dentistry, Mansoura University . The participant will be classified into four groups :group I and II are test groups but group III and IV are control groups .Patients in group I will be treated with melatonin loaded nanoparticle gel while in group II will be treated with melatonin and metformin loaded nanoparticles which will be applied weekly for four weeks after SRP had been completed and group III will be treated with placebo gel while group IV will be treated with only scaling and root planning.
- Conditions
- Bone Loss in Jaw
- Being tested
- Melatonin gel, Metformin and melatonin gel, placebo gel, scaling and root planning
- Keywords
- nanoparticles, melatonin, metformin, intra-bony defect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin gelDrug
local application of Melatonin gel into the periodontal pocket using a syringe with a blunt cannula until the pocket will be completely filled. It will be applied once weekly for four weeks. After insertion of the local drug delivery system, the region will be secured with a periodontal pack
Metformin and melatonin gelDrug
local application of Metformin and melatonin gel into the periodontal pocket using a syringe with a blunt cannula until the pocket will be completely filled. It will be applied once weekly for four weeks. After insertion of the local drug delivery system, the region will be secured with a periodontal pack
placebo gelDrug
Local application of empty nanoparticles gel into the periodontal pocket using a syringe with a blunt cannula until the pocket will be completely filled. It will be applied once weekly for four weeks. After insertion of the local drug delivery system, the region will be secured with a periodontal pack.
scaling and root planningProcedure or surgery
full mouth supra- and subgingival scaling and root planning will be performed, and all periodontitis patients will be treated with ultrasonic tips and Gracey curettes for meticulous removal of subgingival and supragingival plaque and calculus.
| Study group | Role | What they receive |
|---|---|---|
| melatonin loaded nanoparticle (test group) | Active comparator | 13 patients will be treated with melatonin loaded nanoparticle gel as adjunct to scaling and root planning .it will be applied once weekly for four weeks. Receives: Drug: Melatonin gel; Procedure: scaling and root planning |
| melatonin and metformin loaded nanoparticle (test group) | Active comparator | 13 patients will be treated with melatonin and metformin loaded nanoparticle gel as adjunct to scaling and root planning .It will be applied once weekly for four weeks. Receives: Drug: Metformin and melatonin gel; Procedure: scaling and root planning |
| placebo gel (control group) | Placebo comparator | 13 patients will be treated with placebo gel as adjunct to scaling and root planning .It will be applied once weekly for four weeks. Receives: Drug: placebo gel; Procedure: scaling and root planning |
| no gel (control group) | Other | 13 patients will be treated with only scaling and root planning .. Receives: Procedure: scaling and root planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic assessment
all the radiographic parameters will be measured on cone beam computed radiography (CBCT) .The depth of intra bony defect will be measured from cemento enamel junction(CEJ) to base of the defect (BD).The Height of the defect from CEJ to the crest of bone adjacent to the defect and the width of the defect will be from highest point of alveolar crest to dental root adjacent to defect .
Measured: all the parameter will be evaluated after 6 months
Secondary outcomes (1)
plaque index according to Silness P.Loe H 1964
Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. The scores from the four areas of the tooth are added and divided by four in order to give the plaque index for the tooth with the following scores and criteria:
The Plaque Index System
0 No plaque
- A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
- Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.
- Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start14 Dec 2022
- Primary completionMay 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Loss in JawStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amira ragab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amira ragab, Mansoura University
- Investigators
- Amira R AL-Agooz, Principal investigator, Mansoura University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906563
- Sponsor's protocol ID
- A06011122
- Status last verified
- Jun 2023
- First submitted
- 14 Mar 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Melatonin and Metformin Loaded Nanoparticles in the Treatment of Periodontal Intra-bony Defects: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05906563
- Acronym / sponsor ID
- A06011122
- Conditions
- Bone Loss in Jaw
- Keywords
- nanoparticles, melatonin, metformin, intra-bony defect
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Amira ragabUniversity, hospital or other
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 18 Jun 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 goal of this clinical trial is to assess the effectiveness of local delivery of melatonin and metformin loaded nanoparticle gel as adjunct to scaling and root planning (SRP) in the treatment of periodontal intra bony defect.
fifty two healthy patients(n=52) with at least one periodontal intra-bony defect will be included in the study, all selected patients will be motivated about the benefit of plaque control and periodontal treatment . The participant will be selected from outpatient clinic of the Department of Oral Medicine and Periodontology , Faculty of dentistry, Mansoura University . The participant will be classified into four groups :group I and II are test groups but group III and IV are control groups .Patients in group I will be treated with melatonin loaded nanoparticle gel while in group II will be treated with melatonin and metformin loaded nanoparticles which will be applied weekly for four weeks after SRP had been completed and group III will be treated with placebo gel while group IV will be treated with only scaling and root planning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| melatonin loaded nanoparticle (test group) | Active comparator | Drug: Melatonin gel, Procedure: scaling and root planning13 patients will be treated with melatonin loaded nanoparticle gel as adjunct to scaling and root planning .it will be applied once weekly for four weeks. |
| melatonin and metformin loaded nanoparticle (test group) | Active comparator | Drug: Metformin and melatonin gel, Procedure: scaling and root planning13 patients will be treated with melatonin and metformin loaded nanoparticle gel as adjunct to scaling and root planning .It will be applied once weekly for four weeks. |
| placebo gel (control group) | Placebo comparator | Drug: placebo gel, Procedure: scaling and root planning13 patients will be treated with placebo gel as adjunct to scaling and root planning .It will be applied once weekly for four weeks. |
| no gel (control group) | Other | Procedure: scaling and root planning13 patients will be treated with only scaling and root planning .. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with at least one intra-bony defect diagnosed clinically and radiographically
Key exclusion criteria (7 listed)
- Patients with systemic diseases.
- Pregnant and lactating females.
- Smokers and tobacco chewers.
- History of antibiotic and periodontal therapy in the last 3 months.
- Patients not compliant with oral hygiene procedures.
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 |
|---|---|---|
| Melatonin gellocal application of Melatonin gel into the periodontal pocket using a syringe with a blunt cannula until the pocket will be completely filled. It will be applied once weekly for four weeks. After insertion of the local drug delivery system, the region will be secured with a periodontal pack | Drug | melatonin loaded nanoparticle (test group) |
| Metformin and melatonin gellocal application of Metformin and melatonin gel into the periodontal pocket using a syringe with a blunt cannula until the pocket will be completely filled. It will be applied once weekly for four weeks. After insertion of the local drug delivery system, the region will be secured with a periodontal pack | Drug | melatonin and metformin loaded nanoparticle (test group) |
| placebo gelLocal application of empty nanoparticles gel into the periodontal pocket using a syringe with a blunt cannula until the pocket will be completely filled. It will be applied once weekly for four weeks. After insertion of the local drug delivery system, the region will be secured with a periodontal pack. | Drug | placebo gel (control group) |
| scaling and root planningfull mouth supra- and subgingival scaling and root planning will be performed, and all periodontitis patients will be treated with ultrasonic tips and Gracey curettes for meticulous removal of subgingival and supragingival plaque and calculus. | Procedure or surgery | melatonin and metformin loaded nanoparticle (test group), melatonin loaded nanoparticle (test group), no gel (control group), placebo gel (control group) |
Primary outcome
Radiographic assessment
Time frame: all the parameter will be evaluated after 6 months
all the radiographic parameters will be measured on cone beam computed radiography (CBCT) .The depth of intra bony defect will be measured from cemento enamel junction(CEJ) to base of the defect (BD).The Height of the defect from CEJ to the crest of bone adjacent to the defect and the width of the defect will be from highest point of alveolar crest to dental root adjacent to defect .
1 secondary outcome
plaque index according to Silness P.Loe H 1964
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
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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.
Amira R AL-Agooz principal investigator
Mansoura University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin gel, Metformin and melatonin gel and scaling and root planning in people with Bone Loss in Jaw, run by Amira ragab 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 1 inclusion and 7 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 18 Jun 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Radiographic assessment (time frame: all the parameter will be evaluated after 6 months). 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 18 Jun 2023.