Assessment of Rapid Osseointegration of Dental Implants with Different Coatings

NCT06650280 — Not applicable, Completed, 45 participants, October University for Modern Sciences and Arts

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Assessment of Osseointegration of Dental Implants with Three Different Coatings for Early Loading Purpose and Marginal Bone Loss in the Posterior Maxilla. a Randomized Clinical Trial

Registry	NCT06650280
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	45 (Actual)
Sponsor	October University for Modern Sciences and Arts (Other)
Conditions	Dental Implants, Hyaluronic Acid
Interventions	Hyaluronic Acid (HA), nano-hydroxyapatite, sandblasted acid etched (Other)
Dates	start 2023-02-01, primary completion 2024-02-01, completion 2024-06-01, first posted 2024-10-21, last updated 2024-10-21
Locations	1 site in Egypt

-Summary

The study will assess early osseointegration of dental implant with three different coating materials through secondary implant stability

Expand all sections · Collapse all

+Detailed description

Dental implants with sandblasted acid itched coating, nano-hydroxyapatite coating, and hyalouronic acid coating will be placed in the posterior maxilla to restore a missing tooth. Implant stability by the use of Ostell will be measured immediately post-operative, 4, 6, and 12 weeks post-operative.

marginal bone loss around the implants will be compared immediately after final restoration delivery and after one year

+Arms and interventions

Arm	Type	Interventions	Description
sandblasted acid etched group	Experimental	Other: sandblasted acid etched	sandblasted acid etched coated implants will be allocated to this arm
nano-hydroxyapatite group	Active comparator	Other: nano-hydroxyapatite	nano-hydroxyapatite coated implants will be allocated to this arm
hyaluronic acid group	Experimental	Other: Hyaluronic Acid (HA)	hyaluronic acid coated implants will be allocated to this arm

Hyaluronic Acid (HA) (Other): hyaluronic acid coated implants will be placed in posterior maxilla to evaluate rapid osseointegration
nano-hydroxyapatite (Other): nano-hydroxyapatite coated implants will be placed in posterior maxilla to assess rapid osseointegration
sandblasted acid etched (Other): SLA coated implants will be placed in posterior maxilla and implant stability will be evaluated

+Outcome measures

Primary outcomes

rapid osseintegration [immediately post-operative, 4, 6, and 12 weeks post-operative]: rapid osteointegration of dental implants will be evaluated by the use of Ostell device which measures primary and secondary stability expressed as ISQ measures ranging from zero till 90

Secondary outcomes

marginal bone loss [immediately after final restoration delivery and one year post-operative]: the bone height from implant's platform till implant's tip will be measured and compared between immediately after final restoration delivery and after one year

+Eligibility

Sex: All, ages: 18 Years to 49 Years, accepts healthy volunteers

Inclusion Criteria:

1. Patients with missing at least one maxillary posterior tooth
2. Patients free from any systemic disease
3. Patients who approve to be included in the trial and sign the informed consent
4. Patients with no intra-bony defect.
5. Adults aged 18 years old and above

Exclusion Criteria:

1. Patients who are allergic to titanium
2. Heavy smoker patient
3. Patients receiving chemotherapy or radiotherapy
4. Patients who refused to be included in the trial

+Locations (1)

Facility	City	Country	Status
Faculty of Dentistry, MSA University	Giza	Egypt

+Publications

Atsumi M, Park SH, Wang HL. Methods used to assess implant stability: current status. Int J Oral Maxillofac Implants. 2007 Sep-Oct;22(5):743-54. PMID 17974108

+Investigators

Mohamed Hamdy, Lecturer, Principal investigator, Faculty of Dentistry, MSA University, Egypt