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Aangepaste Elamrousy-aanpak voor onmiddellijke plaatsing van implantaten met behulp van de Socket Sheild-techniek

31 oktober 2026 bijgewerkt door: Walid Elamrousy, Kafrelsheikh University

Klinische en radiografische veranderingen peri-implantaat na onmiddellijk geplaatste, onmiddellijk geladen tandheelkundige implantaten met behulp van een Socket Shield-benadering met autogene hele tandtransplantaat versus xenotransplantaat: gerandomiseerde klinische fase

The current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous whole tooth graft (AWTG) with socket shield approach (SSA) and compared this approach to socket shield technique with xenograft.

The present study included 63 patients, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation using socket shield protocol, while group II patients underwent the same procedure, but the shield/fixture jumping gap was grafted by xenograft. finally group III was grafted by AWTG that was created using the decoronated crown and the extracted palatal portion of the tooth; and then placed in the peri-implant gap defect.

Studie Overzicht

Gedetailleerde beschrijving

It has been demonstrated that utilizing dental implants to replace lost teeth is a predictable clinical choice. Promising outcomes of immediate implant insertion in conjunction with immediate loading/provisionalization (Type 1A implant protocol according to Gallucci et al has been reported to provide major benefits in terms of better esthetic and psychosocial impacts, shorter treatment duration, minimal surgical interventions and preservation of peri-implant bone and soft tissue.

However, because of technically sensitive and sophisticated surgery required for Type 1A protocol, high risk of early implant failure was noticed particularly in conditions that might complicate that protocol as deficient facial bone plate, soft tissues deficiencies and thin gingival phenotype. Furthermore, those conditions also were found to be responsible for midfacial mucosal recession (MFMR), papillary recession and resorption of facial plate that deteriorates the clinical, radiological, and esthetic outcomes of Type 1A protocol. Consequently, alternate approaches would be suggested to improve the clinical and esthetic concerns associated with immediate implantation and loading such as buccal gap grafting, guided bone regeneration and socket shield approach.

In order to maintain the facial bone plate for prompt Type 1A protocol in esthetic zone, the SSA has been developed by Hürzeler et al. in 2010 as a potential therapeutic approach through maintaining the facial portion of the root and thus preserving the periodontal ligament and its vascularity that nourishes the tooth's bundle bone. The FSS functions as a natural barrier that prevents buccal bone resorption and enhances tissue contouring, both of which contribute to the achievement of predictable esthetic outcomes. Additionally, the FSS serves as a guide to ensure the implant is positioned correctly. SSA in conjunction with immediate loading reduces the frequency of clinical sessions and reduces the necessity for both soft and hard tissue grafts.

It has been recommended to palatally insert the implants in extraction sockets with at least 2 mm jumping gap between the fixture and the FSS. Significantly, this gap denotes the future buccal bone that will directly contribute to the buccal contour and impact the soft tissue levels. For jumping gaps smaller than 2 mm, bone heals spontaneously, while gaps bigger than 2 mm are advised to be augmented.

AWTG is obviously very advantageous as it exhibits superior osteoconductive and osteoinductive capacity with high biocompatibility and comparable physico-chemical characteristics to autogenous bones. AWTG was successfully employed for augmenting of peri-implant bone defects, with excellent clinical and radiographic outcomes. Similarly, both AWTG and autogenous demineralized dentin graft were equally effective at reducing dimensional losses in alveolar ridge preservation. The production of demineralized dentin is time-consuming, cost-intensive and complicated, which restricts its widespread use in clinics.

In the light of this, the current study was conducted to assess and compare the effectiveness of AWTG versus xenograft for augmenting the FSS/fixture jumping gap around immediately placed implants using SSA with immediate temporization in the maxillary esthetic zone.

To the best of our knowledge, this study is the first to use AWTG for filling the peri-implant jumping gap following SSA and highlight its impact on peri-implant soft and hard tissue parameters compared to xenograft.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

63

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Kafr ash Shaykh, Egypte, 76130
        • Walid Elamrousy

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 45 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • above the age of 18years
  • presence of non-restorable maxillary anterior tooth
  • had sufficient bone volume and
  • The primary stability at insertion not less than 35 N

Exclusion Criteria:

  • history of systemic condition

  • history of using bisphosphonates or other drugs that might impact bone turnover

  • a history of smoking during the previous five years,

  • a history of any acute infections at the surgical site,

  • teeth having root resorptions

  • massive periodontal destruction

    , the presence of any systemic diseases;

  • intake of drugs that may alter bone metabolism

  • presence of acute infection

  • infra-bony horizontal tooth fracture

  • facial vertical root fracture;

  • root resorption; mobile teeth

  • malaligned teeth,

  • active periodontitis at the implantation site.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Immediate Implant Placement Using Socket Shield Technique alone

after insertion of immediate implant Using Socket Shield Technique, the bone defect between the socket shield and the implant fixture will be left ungrafted

the jumping gap will be left ungrafted

Experimenteel: Immediate Implant Placement Using Socket Shield Technique with xenograft

the shield/fixture jumping gap will be grafted with xenograft

the jumping gap will be filled with xenograft

Experimenteel: Modified Elamrousy Approach for Immediate Implant Placement Using Socket Shield Technique

Immediate Implant Placement Using Socket Shield Technique with autogenous whole tooth graft after immediate implantation using Socket Shield Technique, the palatal root portion and the decoronated crown will be converted to autogenous whole tooth graft and used for grafting the defect between the socket shield and the implant fixture

the jumping gap will be filled with AWTG

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Horizontal bone width
Tijdsspanne: 24-month.

Measuring the buccolingual width of the ridge at the CBCT sagittal/axial section was carried out by calculating the distance between the outer boundaries of the palatal and facial bony plates horizontally at a distance of 2 mm away from the implant shoulder apically

24-month.
Stability Quotient of dental implant (SQDI)
Tijdsspanne: 24-month.

Osstell TM was used to record the primary stability.ISQ, or Implant Stability Quotient, is a scale from 1 to 100 and is a measure of the stability of an implant. The ISQ scale has a non-linear correlation to micro mobility. With more than 1400 scientific references, investigators now know that high stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability.

24-month.
pink esthetic score (PES)
Tijdsspanne: 24-month.

The pink esthetic score (PES) evaluates the esthetic outcome of soft tissue around implant-supported single crowns in the anterior zone by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency.Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES was 14

24-month.
Midfacial Mucosal Alterations
Tijdsspanne: 24-month.

digital intraoral scans were recorded. To quantify the vertical changes in the soft tissues around implants buccally, the collected scans were digitally superimposed via matching Gom inspect software

24-month.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
facial marginal bone level (FMBL)
Tijdsspanne: 24-month.

Utilizing CBCT sagittal sections, the BMBL was evaluated by computerized analysis. Navigation was done on the multiplanar display until the implant's precise same-view location was established on the reformatted cross-sectional section and panoramic view.

24-month.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Walid AH Elamrousy, PhD, Faculty of Oral and Dental Medicine, Kafrelsheikh University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

14 februari 2024

Primaire voltooiing (Werkelijk)

15 maart 2026

Studie voltooiing (Werkelijk)

19 maart 2026

Studieregistratiedata

Eerst ingediend

7 februari 2024

Eerst ingediend dat voldeed aan de QC-criteria

9 februari 2024

Eerst geplaatst (Werkelijk)

16 februari 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

31 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

IPD will not be shared with other researchers

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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