Assessment of Immediate Implant Stability When Adding Mixture of Hyaluronic Acid and Melatonin

NCT03692026 | Unknown Phase 4 DMC

• 1 other identifier: PERIO 1405
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Placing implants immediately after tooth extraction offers several advantages such as preventing bone resorption, maintaining alveolar crest width and height, reducing surgical procedures and treatment time, in addition to good esthetic results. Immediate implant placement after tooth extraction is often associated with a residual gap between the implant surface and the residual bone walls. Osseointegration between the implant surface and the surrounding osseous walls of the extraction socket should increase using materials that promote new bone formation. Since both melatonin and hyaluronic acid are thought to have a positive effect on increasing osseointegration and decreasing inflammation of the tissues; the investigators want to test if adding a mix of hyaluronic acid and melatonin to immediately implant, will give a better implant stability, decreased peri-implant bone loss and decreased post-operative pain versus immediate implant placement without adding any material.

Conditions

Immediate Dental Implant

Keywords

post-extraction implant, dental implant; melatonin; Hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• Implant stability

  Measuring the implant stability using Ostell device

  six months

Secondary Outcomes (2)

• Peri-implant horizontal bone changes

  six months

• post-operative pain

  six months

Study Arms (2)

Study group

EXPERIMENTAL

Immediate implant placement in fresh extraction sockets with addition of Hyaluronic acid and Melatonin mixture to the implant surface, into the extraction socket and to the peri-implant area.

Procedure: Immediate implant placement; Drug: Hyaluronic acid and Melatonin Mixture

Control group

ACTIVE COMPARATOR

Immediate implant placement in fresh extraction sockets without adding any material.

Procedure: Immediate implant placement

Interventions

Immediate implant placement PROCEDURE

implants will be placed in freshly extraction sockets with or without application of Hyaluronic acid and Melatonin mixture.

Also known as: early implant placement

Control group; Study group

Hyaluronic acid and Melatonin Mixture DRUG

a mixture of hyaluronic acid and melatonin will be prepared and added topically to the implant surface, extraction socket and peri-implant area for the study group

Study group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old. .single non-restorable teeth in the inter-bicuspid area. .adequate bone volume for the dental implant procedure. .compliant to oral hygiene measures. .accepting to sign an informed consent to undergo the treatment.

You may not qualify if:

• Heavy smokers. .Systemic disease that contraindicates implant placement or surgical procedures.
• No or poor patient's compliance.
• Psychological problems.
• Periapical pathosis at the site of intervention.
• Pregnant females.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (5)

• de Brito Bezerra B, Mendes Brazao MA, de Campos ML, Casati MZ, Sallum EA, Sallum AW. Association of hyaluronic acid with a collagen scaffold may improve bone healing in critical-size bone defects. Clin Oral Implants Res. 2012 Aug;23(8):938-42. doi: 10.1111/j.1600-0501.2011.02234.x. Epub 2011 Jun 21.

  PMID: 21689163 BACKGROUND

• Botticelli D, Berglundh T, Lindhe J. Hard-tissue alterations following immediate implant placement in extraction sites. J Clin Periodontol. 2004 Oct;31(10):820-8. doi: 10.1111/j.1600-051X.2004.00565.x.

  PMID: 15367183 BACKGROUND

• Swami V, Vijayaraghavan V, Swami V. Current trends to measure implant stability. J Indian Prosthodont Soc. 2016 Apr-Jun;16(2):124-30. doi: 10.4103/0972-4052.176539.

  PMID: 27141160 RESULT

• El-Gammal MY, Salem AS, Anees MM, Tawfik MA. Clinical and Radiographic Evaluation of Immediate Loaded Dental Implants With Local Application of Melatonin: A Preliminary Randomized Controlled Clinical Trial. J Oral Implantol. 2016 Apr;42(2):119-25. doi: 10.1563/aaid-joi-D-14-00277. Epub 2015 Jun 23.

  PMID: 26103559 RESULT

• Paolantonio M, Dolci M, Scarano A, d'Archivio D, di Placido G, Tumini V, Piattelli A. Immediate implantation in fresh extraction sockets. A controlled clinical and histological study in man. J Periodontol. 2001 Nov;72(11):1560-71. doi: 10.1902/jop.2001.72.11.1560.

  PMID: 11759868 RESULT

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Mona Darhous, PhD

  Professor of Periodontology. Faculty of Oral and Dental Medicine. Cairo University

  STUDY CHAIR

• Mona Shoeib, PhD

  Professor of Periodontology. Faculty of Oral and Dental Medicine. Cairo University

  STUDY DIRECTOR

• Ahmed El Barbary, PhD

  Ass. Professor of Periodontology. Faculty of Oral and Dental Medicine. Cairo University

  STUDY DIRECTOR

Central Study Contacts

Azza M Nasr, MSc

CONTACT

+201003551727; azzanasr81@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Main investigator

Model Details: It's a Randomized Clinical Trial

Study Record Dates

• First Submitted: September 29, 2018
• First Posted: October 2, 2018
• Study Start: October 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: June 1, 2020
• Last Updated: October 3, 2018

Record last verified: 2018-10