Post Extraction Alterations Following Ridge Preservation In The Esthetic Zone Using Partially Demineralized Autogenous Dentine Graft Versus Xenograft

NCT06552793 | Recruiting

• 1 other identifier: 21524PER6-3-1
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

the aim of this study is to establish if there are clinical, radio-graphical and histomorphometrical differences between using Partially Demineralized Dentin graft versus Xenograft in the esthetic zone. as a clinical application in alveolar bone regeneration procedures related to implant dentistry, including socket preservation, alveolar ridge augmentation, after tooth extraction in the esthetic zone. After extraction of non-restorable teeth in the esthetic zone, will ridge preservation with application of partially demineralized autogenous dentin graft produce less hard tissue changes compared to xenograft? The initial therapy consists of periodontal treatment (phase I therapy) including supragingival scaling, subgingival debridement if needed, adjustment of faulty restoration and polishing. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques. Flapless and atraumatic tooth extraction will be initiated, Then the sockets will be carefully packed with the allocated graft material that are shaped to match the individual size and contours of each socket. Once the grafts are properly adapted to the sockets, they will be covered with collagen membrane. The membrane will be shaped to extend 2-3 mm beyond the margins of the extraction socket and positioned just beneath the marginal mucosa. To ensure its stability, a cross-suture will be performed, securing the membrane in place. Intervention group: The socket will be filled with partially demineralized autogenous dentin graft Control group: The socket will be filled with xenograft . For both groups, All the subjects will be evaluated at pre-surgical, baseline and 6 months post surgical months for clinical parameters and baseline( immediate post-surgical and 6 months post-surgical . Outcomes: Change in radiographic horizontal ridge width at 1mm below the most coronal aspect of the crest , Change in radiographic horizontal ridge width at 3 and 5mm below the most coronal aspect of the crest,Change in radiographic buccal ridge height , Change in radiographic buccal ridge height ,Change in radiographic Palatal ridge height,Percentage of new vital bone formation,Percentage of residual bone graft,Implant Primary Stability. Detailed Description: This study aims to evaluate clinical, radiographic and histomorphometrica

Conditions

Socket Preservation

Keywords

socket preservation; ridge preservation; autogenoues partially demineralized dentin graft; xenograft

Outcome Measures

Primary Outcomes (1)

• Change in radiographic horizontal ridge width

  CBCT scans will be performed at baseline and 6 months postoperatively. Measurements will be taken at both time points using identical reference points and lines. To establish a reference, the most apical point of the extraction socket will be identified on the baseline image, and two reference lines will be drawn. The vertical reference line will be placed at the midpoint of the extraction socket, intersecting the apical reference point. Additionally, a horizontal reference line will be drawn perpendicular to the vertical line, passing through the apical reference point.The horizontal ridge width will be measured at three specific levels: 1 mm, 3 mm, and 5 mm below the most coronal aspect of the crest. These measurements will be denoted as HW-1, HW-3, and HW-5, respectively.

  after 6 months postoperatively

Secondary Outcomes (3)

• Change in radiographic buccal and palatal ridge height:

  after 6 months postoperatively.

• Percentage of new vital bone formation and residual graft

  after 6 months postoperatively

• Implant Primary Stability

  after 6 months postoperatively

Study Arms (2)

Autogenous partially demineralized dentin graft

EXPERIMENTAL

Following atraumatic tooth extraction, curettes will be used to remove granulation tissues, and the socket will be irrigated with sterile normal saline.Then the socket will be filled with Autogenous partially demineralized dentin graft (that will be prepared using tooth transformer device) followed by placement of a collagen membrane to cover the socket(The membrane will be shaped to extend 2-3 mm beyond the margins of the extraction socket and positioned just beneath the marginal mucosa) . Suturing technique will be a criss cross horizontal mattress to ensure that most of the grafting material is covered.

Biological: autogenous partially demineralized dentin graft

Xenograft

ACTIVE COMPARATOR

Following atraumatic tooth extraction, curettes will be used to remove granulation tissues, and the socket will be irrigated with sterile normal saline.Then the socket will be filled with xenograft graft followed by placement of a collagen membrane to cover the socket.( The membrane will be shaped to extend 2-3 mm beyond the margins of the extraction socket and positioned just beneath the marginal mucosa) Suturing technique will be a criss cross horizontal mattress to ensure that most of the grafting material is covered.

Biological: Xenograft

Interventions

autogenous partially demineralized dentin graft BIOLOGICAL

tooth cleaning : form decay, tartar, soft tissue debris, fillings, cement then cut into fragments (5×5 mm) and inserted into the milling device (Tooth Transformer, Milan, Italy). A disposable box containing disposable liquid solutions will be inserted into the device to ensure the demineralization of the graft with 0.1 M hydrochloric acid, 10% hydrogen peroxide, and demineralized water as a wash.The decontamination of the granules will take place through UVA rays and ultrasounds, with temperature variations always lower than 43 ◦C to avoid damage to proteins. After 25 min, particle graft biomaterials will be obtained. The particles size will range from 815 µm with peaks up to 1110 µm.

Autogenous partially demineralized dentin graft

Xenograft BIOLOGICAL

Cortico-cancallous Bovine powder

Xenograft

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with non-restorable teeth and Type II extraction socket in the esthetic zone indicated for extraction for periodontal, carious or traumatic reasons.
• Healthy patients with adequate oral hygiene (bleeding on probing ≤20%; Plaque index ≤20%).
• Adult patients above 18 years old.
• Patients accept 6-months follow-up period and provide an informed consent.

You may not qualify if:

• Heavy smokers (more than 10 cigarettes per day or an electronic cigarette dose of \>6 mg/ml of nicotine).
• Patients reporting systemic conditions that may compromise healing or bone metabolism (eg: diabetes).
• Patients with poor oral hygiene (bleeding on probing \>20%; Plaque index \>20%)
• The presence of acute periapical infection.
• The presence of severe periodontal destruction.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Manal M Hosny, Professor

  Cairo University

  STUDY DIRECTOR

• Weam A El-Battawy, Ass. Prof.

  Cairo University

  STUDY CHAIR

• Riham A Alshikh Hani Alkurdee, Bachelor

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Riham A Alshikh Hani Alkurdee, Bachelor

CONTACT

+201021931950; riham.ahmad@dentistry.cu.edu.eg

Weam El-Battawy, Ass. Prof.

CONTACT

Weamelbattawy@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator Riham Ahmad Master degree student, periodontology department, faculty of dentistry, Cairo University

Model Details: A randiomized clinical trial

Study Record Dates

• First Submitted: August 10, 2024
• First Posted: August 14, 2024
• Study Start: May 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: February 1, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

EG (1)