Melatonin in Posterior Mandible Extraction Socket
Effect of Local Melatonin Gel Versus Placebo Gel Application on Bone Regeneration in Mandibular Posterior Teeth Extraction Sockets With Radiographic and Histopathological Evaluation: A Randomized Clinical Trial
This study will be conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University. It will include patients aged 18-30 years presenting with non-restorable mandibular molars indicated for extraction and delayed implant placement.
Eligible patients will be randomly allocated into two equal groups:
- Group I (Intervention group): Extraction sockets will be filled with locally applied melatonin gel.
- Group II (Control group): Extraction sockets will be filled with placebo gel. All patients will undergo atraumatic tooth extraction under local anesthesia, followed by socket curettage, saline irrigation, application of the allocated gel, collagen membrane coverage, and primary wound closure.
Postoperative care will include standardized medications and oral hygiene instructions. Patients will be followed up clinically and radiographically. CBCT will be used to assess the primary outcome, which is the dimensional change in vertical alveolar bone height (ΔH). At 12 weeks, core biopsy specimens will be obtained for histopathological assessment of bone quality, including newly formed bone, bone maturation, trabecular architecture, and osteoblastic activity.
Sample size: The total sample size will be determined based on the primary outcome (ΔH), using an appropriate statistical power calculation, with equal allocation between the two groups. The final number of participants will be specified according to the statistician's sample size calculation.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients aged 18-30 years
- Presence of non-restorable mandibular molars indicated for extraction
- Patients with good general health
- Adequate oral hygiene
- Patients willing to undergo implant placement after 4 months
- Patients who provide informed consent
Exclusion Criteria:
- Patients with systemic diseases affecting bone healing (e.g., uncontrolled diabetes, osteoporosis)
- Patients receiving medications affecting bone metabolism (e.g., corticosteroids, bisphosphonates)
- Heavy smokers
- Presence of acute infection or pathological lesions at the extraction site
- Pregnant or lactating females
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: placebogruppe
|
Eligible patients will undergo atraumatic extraction of non-restorable mandibular molars under local anesthesia, followed by socket curettage and irrigation with sterile 0.9% saline. The extraction socket will be filled with locally applied placebo gel. A collagen membrane will then be adapted to cover the socket, followed by primary wound closure using interrupted sutures. All participants will receive standardized postoperative medications and oral hygiene instructions. Clinical follow-up will be conducted at 3 days and 1 week postoperatively. At 12 weeks, CBCT examination will be performed to assess changes in vertical alveolar bone height (ΔH), followed by core biopsy for histopathological evaluation of bone quality. |
|
Eksperimentell: melatonin group
|
Eligible patients will undergo atraumatic extraction of non-restorable mandibular molars under local anesthesia, followed by socket curettage and irrigation with sterile 0.9% saline. The extraction socket will be filled with locally applied melatonin gel. A collagen membrane will then be adapted to cover the socket, followed by primary wound closure using interrupted sutures. All participants will receive standardized postoperative medications and oral hygiene instructions. Clinical follow-up will be conducted at 3 days and 1 week postoperatively. At 12 weeks, CBCT examination will be performed to assess changes in vertical alveolar bone height (ΔH), followed by core biopsy for histopathological evaluation of bone qualit |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
the dimensional change in vertical alveolar bone height
Tidsramme: 12 weeks
|
radiographically by cone beam C.T |
12 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 91941999
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