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Study to compare the effect of melatonin gel in combination with artificial bone material in treating bony defects caused by gum diseases.

Clinical and Radiological evaluation of periodontal intrabony defects using 1% Melatonin gel with Demineralized freeze-Dried Bone Allograft (DFDBA) and its effect on Receptor Activator of Nuclear factor Kappa-B Ligand (RANKL) and Osteoprotegerin (OPG) levels in Gingival Crevicular Fluid - A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/055039
Enrollment
20
Registered
2023-07-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K053- Chronic periodontitis

Interventions

Intervention1: 1% melatonin gel: Conventional periodontal flap surgery will be done followed by immediate placement of 1% melatonin gel prepared using Carbopal polymer along with Demineralized freeze-

Sponsors

G Laxmi Kavya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with localized or generalized periodontitis of stage-II and stage-III with grade B and C as per 2017 classification 2.Two and three walled intrabony defects with radiologic vertical bone loss of >= 3mm at baseline and a PPD >=5mm when persistent after non-surgical therapy

Exclusion criteria

Exclusion criteria: 1.Patients with poor oral hygiene 2.Uncontrolled systemic diseases 3.Patients under antibiotic therapy 4.Smokers, tobacco chewers 5.Pregnant and lactating women 6.Patients receiving periodontal treatment during last 6 months 7.Patients under melatonin supplement therapies

Design outcomes

Primary

MeasureTime frame
1.Probing pocket depth 2.Clinical attachment level 3.Linear amount of bone fill 4.Bone volume Salivary Biomarkers - 5.RANKL and 6.Osteoprotegerin in GCF Timepoint: 1.Probing pocket depth at baseline 3 months 6 months 2.Clinical attachment level at baseline 3 months 6 months 3.Linear amount of bone fill at baseline & 6 months 4.Bone volume at baseline & 6 months Salivary Biomarkers - 5.RANKL in GCF at baseline & 6 months 6.Osteoprotegerin in GCF at baseline & 6 months—

Secondary

MeasureTime frame
1.Plaque index 2.Sulcus bleeding indexTimepoint: 1.Plaque index at baseline,3 months ,6 months 2.Sulcus bleeding index at baseline,3 months, 6 months—

Countries

India

Contacts

Public ContactDr K Anil Kumar

Vishnu dental college

anilkumar.perio@vdc.edu.in9677209549

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026