Enamel Matrix Derivative for Alveolar Ridge Preservation After Tooth Extraction

NCT05517798 | Unknown DMC

• 1 other identifier: MBRUMHS
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The Global Burden of Disease Study of 2016 considered oral disease as the most common noncommunicable disease that affected half of the world population throughout their lifetime. Dental caries and periodontal diseases may cause pain and discomfort with severe forms of periodontal diseases causing tooth loss. Periodontal disease and tooth loss were estimated to be one of the ten causes of Years Lived with Disability. The dimensional changes in the alveolar ridge following tooth loss have been extensively investigated in the literature. At six months after tooth loss, a systematic review on bone remodelling showed horizontal and vertical bone loss of 29-63% and 11-22%, respectively. Such bone loss may complicate replacement of missing teeth with dental implants. Dental implant is now a common treatment modality. However, the loss of bone volume may not allow the placement of dental implant in an optimal position and may subsequently jeopardize functional and aesthetic implant outcomes. Therefore, the use of bone replacement graft following tooth extraction, as part of a procedure termed alveolar ridge preservation (ARP), has increasingly becoming a common treatment protocol to optimize dental implant placement in the future. A Cochrane review on ARP has demonstrated that there are no significant differences between the plethora of synthetic or biologically driven grafting materials used to minimize changes in width and height of the extraction sockets. Nevertheless, a regenerative agent, known as enamel matrix derivative (EMD), has gained more attention in regenerative therapy over the last 20 years. Several studies demonstrated its ability to enhance wound healing, induce new attachment and promote bone formation in recession and intrabony defects. Over the last two decades, EMD has been successfully used in the periodontal regeneration of intrabony defects. EMD has the potential to cause early vascularization and support early bone formation, hence, it can be considered as a potential regenerative agent for ARP when used with appropriate carrier material. Moreover, the majority of studies showed that bone substitutes generally performed well in small or contained defects compared with non-grafted sites, but there is lack of information regarding the efficacy of different bone substitute materials in large defects. Short-term follow-up studies of three to six months have also dominated the literature when the main aim of the ARP is to develop a site that optimise long-term implant outcomes. Such aim requires evaluating the long-term performance of dental implants placed in preserved ridges and reporting patient outcomes in well-conducted randomized controlled trial. The aim of the present clinical trial is to evaluate the adjunctive use of EMD in promoting the desired vascularization and bone fill in small and large defects following tooth extraction and report on the long-term implant and patient outcomes.

Conditions

Alveolar Ridge Preservation

Keywords

Alveolar ridge preservation; Dental implants; Enamel matrix derivative

Outcome Measures

Primary Outcomes (4)

• Implant survival / success rate after one year

  'Implant survival' means that implants are still in the mouth at the time of examination

  1 year

• Patient postoperative experience

  Postoperative experience means any events occurring after and relating to the procedure

  1 week

• Implant survival / success rate after two years

  'Implant survival' means that implants are still in the mouth at the time of examination

  2 years

• Implant survival / success rate after three years

  'Implant survival' means that implants are still in the mouth at the time of examination

  3 years

Secondary Outcomes (4)

• Changes in width and height of alveolar ridge

  6 months

• Bone quality

  1 day

• Need for additional bone augmentation

  1 day

• Changes in peri-implant marginal bone level

  1 year

Study Arms (2)

Xenograft + resorbable collagen membrane

ACTIVE COMPARATOR

Bone grafting material (bovine origin) + resorbable collagen membrane (porcine origin)

Procedure: Alveolar ridge preservation

Xenograft combined with EMD + resorbable collagen membrane

ACTIVE COMPARATOR

Bone grafting material (bovine origin) with enamel matrix derivative (porcine origin) + resorbable collagen membrane (porcine origin)

Procedure: Alveolar ridge preservation

Interventions

Alveolar ridge preservation PROCEDURE

Alveolar ridge preservation is a method of decreasing bone resorption following tooth extraction and facilitating prosthetically-driven implant placement

Xenograft + resorbable collagen membrane; Xenograft combined with EMD + resorbable collagen membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or over.
• Require extraction of anterior or posterior single tooth due to caries, endodontic and prosthetic complications.
• The tooth that requires extraction is bordered by two teeth.
• Controlled oral hygiene (full-mouth plaque and bleeding scores ≤ 25% at baseline).
• Good compliance and commitment to attend follow-up review appointments.
• Willing to provide informed consent.

You may not qualify if:

• Localised / generalised periodontitis.
• Presence of acute periapical lesion.
• Bone metabolic disease and/or taking medications that affect bone metabolism.
• Long term use of non-steroidal anti-inflammatory medications.
• History of malignancy, radiotherapy or chemotherapy.
• Pregnant or lactating women.
• Severe bruxism or parafunctional habits.
• Large occlusal discrepancies.

Sponsors & Collaborators

• Mohammed Bin Rashid University of Medicine and Health Sciences: lead

Study Sites (1)

Dubai Dental Hospital

Dubai, 505097, United Arab Emirates

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Associate Professor Momen Atieh

Study Record Dates

• First Submitted: September 11, 2021
• First Posted: August 26, 2022
• Study Start: September 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)