- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07610876
Autologous Demineralized Dentin Graft With or Without Melatonin for Immediate Implant Osseointegration
Effect of Autologous Demineralized Dentin Graft With or Without Melatonin Gel on the Osseo Integration of Immediately Placed Implants: A Randomized Clinical Study
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Patients requiring extraction and immediate implant placement in the maxillary premolar region often present with peri-implant defects and jumping gaps that may compromise osseointegration and long-term implant success. Autogenous bone grafts are considered the gold standard for bone augmentation because of their osteogenic, osteoinductive, and osteoconductive properties; however, they are associated with donor-site morbidity, limited availability, and increased surgical time. Recently, autologous demineralized dentin graft (ADDG) derived from extracted teeth has been introduced as a promising alternative grafting material due to its chemical and histological similarity to alveolar bone.
Dentin and bone share a common embryologic origin and similar composition, including type I collagen and low crystalline hydroxyapatite. Demineralized dentin graft material has demonstrated favorable osteoconductive and osteoinductive properties and has been successfully used in guided bone regeneration and immediate implant procedures. In immediate implant placement, the extracted tooth may be processed and reused as graft material to fill the jumping gap around the implant.
Melatonin (N-acetyl-5-methoxytryptamine) is an antioxidant molecule that has demonstrated beneficial effects on bone metabolism and osseointegration. Melatonin reduces osteoclastic activity, promotes osteoblast differentiation, enhances bone formation, and decreases oxidative stress during healing. Previous studies have suggested that local application of melatonin around dental implants may improve early osseointegration and bone healing.
The purpose of this randomized clinical study is to evaluate clinically and radiographically the effect of using melatonin gel in conjunction with autologous demineralized dentin graft on the osseointegration of immediately placed implants.
Sixteen patients with non-restorable maxillary premolar teeth indicated for extraction and immediate implant placement will be recruited from the outpatient clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Suez Canal University. Eligible patients will be randomly allocated into two equal groups. In Group I, immediate implants will be placed and the jumping gap will be filled using autologous demineralized dentin graft alone. In Group II, immediate implants will be placed and the jumping gap will be filled using autologous demineralized dentin graft mixed with melatonin gel.
Clinical assessment will include implant stability measurement using the Penguin device, peri-implant sulcus depth, and modified bleeding on probing index. Radiographic evaluation will be performed using cone beam computed tomography (CBCT) to assess marginal bone loss, buccal bone thickness, buccal bone height, jumping distance, and bone density at baseline, immediately after implant placement, and during follow-up periods up to 9 months postoperatively.
The results of this study may help determine whether the addition of melatonin gel to autologous demineralized dentin graft improves osseointegration and peri-implant bone healing in immediate implant placement procedures.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: B.S.D Abd El Fattah ELSaid Attia
- Telefonnummer: +20100465932
- E-mail: PGS.230043@dent.suez.edu.eg
Studiesteder
-
-
-
Ismailia, Egypten
- Rekruttering
- Suez Canal University, Faculty of Dentistry
-
Kontakt:
- Dean, Faculty of Dentistry, Suez Canal University
- Telefonnummer: (+2064) 3223007
- E-mail: President_office@suez.edu.eg
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Age above 20 years
- Non-restorable maxillary premolar teeth
- Candidates for immediate implant placement
- Intact socket walls
- Jumping gap >2 mm
- Non-smokers or light smokers
- No acute infection
- Adequate bone for primary stability
Exclusion Criteria:
- Heavy smokers
- Bruxism or clenching
- Uncontrolled systemic disease
- Chemotherapy/radiotherapy
- Immunocompromised patients
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: ADDG Alone
Participants in this arm will receive immediate implant placement in the maxillary premolar region with jumping gap filling using autologous demineralized dentin graft (ADDG) alone after extraction of non-restorable teeth.
Clinical and radiographic evaluation will be performed during the follow-up period.
|
Autologous demineralized dentin graft prepared from extracted non-restorable teeth will be used for filling the jumping gap around immediately placed dental implants.
Tooth preparation includes removal of restorations, caries, periodontal ligament, pulp tissue, calculus, and cementum, followed by grinding and demineralization using 2% nitric acid before graft placement.
|
|
Eksperimentel: ADDG + Melatonin Gel
Participants in this arm will receive immediate implant placement in the maxillary premolar region with jumping gap filling using autologous demineralized dentin graft (ADDG) mixed with melatonin gel after extraction of non-restorable teeth.
Clinical and radiographic evaluation will be performed during the follow-up period.
|
Melatonin gel will be mixed with autologous demineralized dentin graft and used for filling the jumping gap around immediately placed dental implants in the maxillary premolar region to enhance osseointegration and peri-implant bone healing.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Implant Stability Quotient (ISQ)
Tidsramme: Baseline and 6 months
|
Measured using Penguin device immediately after implant placement and after 6 months.
|
Baseline and 6 months
|
|
Jumping Distance
Tidsramme: Immediate postoperative and 9 months after implant placement
|
The horizontal bucco-implant gap (jumping distance) will be measured radiographically using CBCT at 0 mm, 2 mm, and 5 mm apical to the implant shoulder as the perpendicular distance from the implant surface to the inner buccal bone plate.
|
Immediate postoperative and 9 months after implant placement
|
|
Marginal Bone Loss
Tidsramme: Immediate postoperative and 9 months after implant placement
|
Marginal bone loss will be assessed radiographically using cone beam computed tomography (CBCT) as the vertical distance from the implant platform to the alveolar crest around the implant.
|
Immediate postoperative and 9 months after implant placement
|
|
Bone Density
Tidsramme: Immediate postoperative and 9 months after implant placement
|
Bone density around the implant will be measured radiographically using CBCT and expressed in Hounsfield units (HU) to evaluate peri-implant bone maturation and osseointegration.
|
Immediate postoperative and 9 months after implant placement
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Buccal Bone Thickness (BBT)
Tidsramme: Preoperative, immediate postoperative, and 9 months after implant placement
|
Buccal bone thickness will be measured radiographically using standardized CBCT scans at 0 mm, 2 mm, and 5 mm apical to the implant shoulder to evaluate horizontal buccal bone dimensional changes around immediately placed implants.
|
Preoperative, immediate postoperative, and 9 months after implant placement
|
|
Buccal Bone Height (BBH)
Tidsramme: Preoperative, immediate postoperative, and 9 months after implant placement
|
Buccal bone height will be assessed radiographically using CBCT as the vertical distance from the implant shoulder to the most coronal buccal bone point.
|
Preoperative, immediate postoperative, and 9 months after implant placement
|
|
Peri-Implant Sulcus Depth (PISD)
Tidsramme: Baseline, 6 months, and 9 months
|
Peri-implant sulcus depth will be measured clinically using a periodontal probe at the buccal, palatal, mesial, and distal aspects around the implant.
|
Baseline, 6 months, and 9 months
|
|
Modified Bleeding on Probing Index (MBOP)
Tidsramme: Baseline, 6 months, and 9 months
|
Modified bleeding on probing index will be recorded clinically using a periodontal probe to evaluate peri-implant soft tissue inflammation around the implant.
|
Baseline, 6 months, and 9 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Hany Kamel Shalaby, Professor of Oral Medicine and Periodontology, Dean Faculty of Dentistry
- Studieleder: Shaima Mohammed Morsy, Assistant Professor of Oral Medicine and Periodontology
- Studieleder: Rasha El-Sayed Afifi, Lecturer of Oral Medicine and Periodontology
- Ledende efterforsker: Abd El Fattah ELSaid Attia, B.S.D, B.S.D
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 854/2024
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Tandimplantater
-
Universidad Complutense de MadridAfsluttetDental Implant-Abutment DesignSpanien
-
Università degli Studi di SassariDr. Dario Melodia; Dr. Milena Pisano; Prof. Silvio Mario Meloni; Prof. Edoardo... og andre samarbejdspartnereIkke rekrutterer endnu
-
Università degli Studi di SassariDr. Dario Melodia; Dr. Milena Pisano; Dr. Aurea Lumbau; Prof. Silvio Mario... og andre samarbejdspartnereIkke rekrutterer endnu
-
Semmelweis UniversityInstitut Straumann AGRekrutteringDental Implant-Abutment Design | Tandimplantater, enkelttandUngarn
-
Università degli Studi di SassariDr. Dario Melodia; Dr. Milena Pisano; Prof. Silvio Mario Meloni; Prof. Edoardo... og andre samarbejdspartnereIkke rekrutterer endnuTandimplantat | Dental Implant-Abutment DesignItalien
-
Università degli Studi di SassariDr. Dario Melodia; Dr. Milena Pisano; Dr. Aurea Lumbau; Prof. Silvio Mario... og andre samarbejdspartnereIkke rekrutterer endnuTandimplantat | Dental Implant-Abutment Design | Edentuous kæbe
-
Mansoura UniversityAfsluttetPeri Implant KnogletabEgypten
-
CochlearAvaniaAfsluttetVoksne Cochlear Implant-modtagereAustralien
-
CochlearAvaniaAfsluttet
-
Kıvanç AkçaHacettepe UniversityAfsluttetCementering (MeSH Unikt ID: D002484) | Dental Implant-Abutment Design (MeSH Unikt ID: D059605) | Krone (MeSH Unikt ID: D003442) overflader | Kontur: Krone (MeSH Unique ID: D003442) - Tandimplantat (MeSH Unique ID: D015921) AbutmentKalkun
Kliniske forsøg med Autologous Demineralized Dentin Graft
-
Kafrelsheikh UniversityNational Research Centre, EgyptRekrutteringAlveolar Ridge Bevaring | Alveolær knogleresorption efter ekstraktionEgypten
-
Soaad Tolba Mohammed Tolba BadawiAfsluttetTandudtrækning | Alveolar Ridge Bevaring | Umiddelbar implantatbelastningEgypten
-
Cairo UniversityRekrutteringBevaring af sokkelEgypten