Treatment Outcome of Short Implant Assisted Mandibular Overdenture

• ClinicalTrials.gov Identifier: NCT03540316
• Recruitment Status: Active, not recruiting
• First Posted: May 30, 2018
• Last Update Posted: July 27, 2021
• Sponsor: Sara Zayed
• Information provided by (Responsible Party): Sara Zayed, Alexandria University

Study Description

Brief Summary:

This study evaluates the use of short dental implants to support mandibular overdenture together with the use of laser therapy for treatment of patients with atrophic ridges. All participants will receive laser therapy; half of participants will receive two short implants and the other half will receive four short implants.

Condition or disease	Intervention/treatment	Phase
Atrophy of Edentulous Mandibular Alveolar Ridge	Combination Product: Two short implants and 2 minutes LLLT; Combination Product: Two short implants and 4 minutes LLLT; Combination Product: Four short implants and 2 minutes LLLT; Combination Product: Four short implants and 4 minutes LLLT	Not Applicable

Detailed Description:

The conventional solution to complete edentulism is the use of complete removable dentures. One negative effect of edentulism is resorption of the edentulous ridge over time. Construction of a successful mandibular complete denture for patients with advanced mandibular ridge resorption is often difficult and on some occasions virtually impossible. It has been proved that when implants are placed, bone gets stimulated resulting in minimal bone loss. But anatomic limitations to implant placement have been observed in atrophic ridges, so short implants introduced as a recent alternative to aggressive surgical procedures proposed to compensate for tissue deficiency. Also, Low Level Laser Therapy (LLLT) has proven success in improving implant stability which is very crucial in short implants. Thus, the purpose of this study is to evaluate and compare the treatment outcome of mandibular overdenture assisted by two short implants versus that assisted by four short implants in combination with LLLT.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment Outcome of Short Implant Assisted Mandibular Overdenture in Combination With Low Level Laser Therapy
• Actual Study Start Date: May 1, 2018
• Estimated Primary Completion Date: December 2023
• Estimated Study Completion Date: January 2024

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Two short implants and 2 minutes LLLT; Patients receiving 2 short dental implants assisted mandibular over-denture and Low level laser therapy (LLLT) for 2 minutes .	Combination Product: Two short implants and 2 minutes LLLT; Patients with edentulous atrophied mandibular ridge will receive 2 short dental implants and LLLT for 2 minutes.
Active Comparator: Two short implants and 4 minutes LLLT; Patients receiving 2 short dental implants assisted mandibular over-denture and LLLT for 2 minutes .	Combination Product: Two short implants and 4 minutes LLLT; Patients with edentulous atrophied mandibular ridge will receive 2 short dental implants and LLLT for 4 minutes.
Active Comparator: Four short implants and 2 minutes LLLT; Patients receiving 4 short dental implants assisted mandibular over-denture and LLLT for 2 minutes .	Combination Product: Four short implants and 2 minutes LLLT; Patients with edentulous atrophied mandibular ridge will receive 4 short dental implants and LLLT for 2 minutes.
Active Comparator: Four short implants and 4 minutes LLLT; Patients receiving 4 short dental implants assisted mandibular over-denture and LLLT for 4 minutes .	Combination Product: Four short implants and 4 minutes LLLT; Patients with edentulous atrophied mandibular ridge will receive 4 short dental implants and LLLT for 4 minutes.

Outcome Measures

Primary Outcome Measures :

1. Assessment of changes in implant stability (Implant Stability Quotient). [ Time Frame: Baseline, 6 months &12 months. ]
   Implant stability can be defined as the absence of clinical mobility. It will be assessed at the time of implant placement (baseline) ,then six months and twelve months later, by the resonance frequency analysis using Osstel devise which measure implant oscillation frequency on the bone;Implant Stability Quotient (ISQ) .

Secondary Outcome Measures :

1. Peri-implant marginal bone changes. [ Time Frame: Baseline, 6 months &12 months. ]
   Radiographic assessment of bone level changes around each implant will be performed to detect peri-implant crestal bone changes using standardised digital periapical x-ray. It will be assessed at the time of implant placement, six months and twelve months later.
2. Assessment of changes in peri-implant probing depth . [ Time Frame: Baseline, 6 months &12 months. ]
   Peri-implant probing depth is the distance between the gingival margin and the most apically probeable portion, in millimetres. It will be measured at four sites of each implant (mesially, labially, distally, lingually) by using a graduated periodontal probe which will be held parallel to the long axis of the implant and introduced to the peri-implant sulcus till there is slight resistance. The mean record for each implant will be calculated. It will be evaluated at time of definitive prosthesis insertion then, six months and twelve months after implant placement.
3. Assessment of changes in modified gingival index [ Time Frame: Baseline, 6 months &12 months. ]
   To qualify the degree of peri-implant inflammation, the modified gingival index will be used. It will be measured at four sites around each implant (mesially, labially, distally, lingually) and the mean record for each implant will be calculated. It will be evaluated at time of definitive prosthesis insertion, then six months and twelve months after implant placement.

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Completely edentulous patients.
• Patients with mandibular resorbed edentulous ridge.
• Medically fit patients with no systemic conditions.
• Class I ridge relation.
• Adequate zone of keratinized mucosa.

Exclusion Criteria:

• Metabolic bone disease or unstable systemic condition.
• Heavy smokers.
• A history of radiotherapy in the head and neck region.
• Physical or mental disability.
• Temporomandibular and neuromuscular disorders.

Contacts and Locations

Locations

Egypt

Faculty of dentistry

Alexandria, Egypt

Sponsors and Collaborators

Sara Zayed

Investigators

• Study Director: Sara Zayed; Alexandria University

More Information

Publications:

Thomason JM, Feine J, Exley C, Moynihan P, Müller F, Naert I, Ellis JS, Barclay C, Butterworth C, Scott B, Lynch C, Stewardson D, Smith P, Welfare R, Hyde P, McAndrew R, Fenlon M, Barclay S, Barker D. Mandibular two implant-supported overdentures as the first choice standard of care for edentulous patients--the York Consensus Statement. Br Dent J. 2009 Aug 22;207(4):185-6. doi: 10.1038/sj.bdj.2009.728.

Maniewicz S, Buser R, Duvernay E, Vazquez L, Loup A, Perneger TV, Schimmel M, Müller F. Short Dental Implants Retaining Two-Implant Mandibular Overdentures in Very Old, Dependent Patients: Radiologic and Clinical Observation Up to 5 Years. Int J Oral Maxillofac Implants. 2017 Mar/Apr;32(2):415-422. doi: 10.11607/jomi.5361.

Mandić B, Lazić Z, Marković A, Mandić B, Mandić M, Djinić A, Miličić B. Influence of postoperative low-level laser therapy on the osseointegration of self-tapping implants in the posterior maxilla: a 6-week split-mouth clinical study. Vojnosanit Pregl. 2015 Mar;72(3):233-40.

Maló P, de Araújo Nobre M, Rangert B. Short implants placed one-stage in maxillae and mandibles: a retrospective clinical study with 1 to 9 years of follow-up. Clin Implant Dent Relat Res. 2007 Mar;9(1):15-21.

• Responsible Party: Sara Zayed, Director, Alexandria University
• ClinicalTrials.gov Identifier: NCT03540316
• Other Study ID Numbers: 01032018
• First Posted: May 30, 2018
• Last Update Posted: July 27, 2021
• Last Verified: July 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Atrophy; Pathological Conditions, Anatomical