Clinical trial NCT02309125: Comparing the Secondary Stability of Dental Implants: Immediate Gradual Loading Versus Early Loading Protocol in Posterior Maxilla
Official title: Split Mouth Clinical Study to Compare the Secondary Stability of Dental Implants Using Immediate Gradual Loading Versus Early Loading Protocol in Posterior Maxilla. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Implant
Transmucosal Healing
Bone Loss
Keywords: immediate gradual loading
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2014-12-05
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this split mouth study is to compare which method is better in reducing bone loss and healing times following implants. Specifically, the two methods investigated will be immediate gradual loading and early loading protocol.

Research Hypothesis Immediate gradual loading using gingival formers is superior to early loading protocols in improving bone quality and thus reducing the healing time.

Detailed description: These two methods (gradual loading and early loading) will both be used in implants patients with the aim to compare which protocol leads to a better outcome for the patient.

A 'better outcome' is defined as the method, which leads to the least crestal bone loss, and the fastest healing time.

Immediate gradually loaded side: will include transmucosal healing of dental implants using gingival formers which will be replaced every 2 weeks by consequent larger size gingival former.i.e. at surgery time the implants will receive 2 mm height gingival former which will be swapped by 3 mm, 4 mm, 5 mm and the last is 6 mm

early loaded side: implants will be submerged from the surgery time till loading time (2 month).

Eligibility criteria: Inclusion criteria

1. Patients with bilateral Partial or complete edentulous areas in maxillary premolar/molar region.
2. Free medical history.
3. Enough bone quantity.
4. Enough keratinized mucosa

Exclusion criteria

1. Systemic disease.
2. Irradiated bone (radiotherapy).
3. Heavy smoking habit.
4. Patients undergoing long-term immunosuppressive therapy.
5. Atrophic ridges.
6. Presence of any local bony lesion.
7. Presence of mandibular parafunctional habits

Primary outcomes:
measure: secondary stability of dental implant (ISQ Osstell Mentol)
timeFrame: 2 month
Secondary outcomes:
measure: Bone loss using Periapical Radiographic (Long Cone Paralleling technique)
timeFrame: 2 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of oral & Dental Medicine. Cairo University
Study officials:
affiliation: Cairo University
name: elhassan mossad, oral surgeon
role: PRINCIPAL_INVESTIGATOR
References:
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