Autogenous Sticky Bone Plus Platelet-rich Fibrin Membrane Versus Xenograft With Collagen Membrane for Posterior Atrophic Mandible

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorAlexandria University

About this trial

Background: Teeth loss in the posterior mandible initiates residual ridge resorption, this causes difficulty in implant placement so ridge augmentation must be done either simultaneous with implant placement or in a staged approach Aim: To evaluate the effect of autogenous sticky bone with PRF membrane and xenograft with collagen membrane with simultaneous implant placement clinically on primary and secondary implant stability, and radiographically on bucco-lingual width gain, bone density and crestal bone loss

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with missing posterior mandibular teeth.

Horizontal bone defect with width < 5.5 mm.

Adequate zone of keratinized tissue

Disqualifiers

Presence of infection or periapical lesions in adjacent teeth.

Medically compromised patients with a condition that affects the procedure.

Insufficient inter-arch distance.

Bruxism or clenching.

Trial design

Design model

Single group

Treatments tested in this trial

  • autogenous sticky bone + PRF membrane

    Other intervention

    Patients in this group will be treated using autogenous sticky bone with PRF membrane.

  • Xenograft + collagen membrane

    Other intervention

    Patients in this group will be treated using a xenograft with a collagen membrane.

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: Test GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in implant stability

Implant stability will be recorded immediately after placement (1ry stability) and after 6 months (2ry stability ) by using osstell device. The result is presented in form of ISQ value from 1 to 100, the higher the ISQ the higher the stability of implant

Time frame
up to 6 months
2

change in bucco-lingual bone thickness

All participants in the study will be advised to undergo CBCT before implant placement to measure bucco-lingual bone thickness, and again 7 days postoperatively and 6 months after implant placement to assess the following.

Time frame
up to 6 months
3

change in marginal bone level

At buccal, lingual, mesial, and distal sites will be evaluated radiographically from the shoulder of the implant to the alveolar crest. The mean marginal bone loss after the placement of implants will be calculated by subtracting baseline value from the values obtained at 6 and 9 months post implant placement

Time frame
up to 9 months
4

change in ridge width

Will be measured immediately and after 6 months, bone width will be measured for each implant at three levels (2, 5, and 10 mm from the alveolar crest) and the mean will be calculated for each implant at each time interval.

Time frame
up to 6 months

Secondary outcomes

1

change in pain scores

Pain will be assessed for 7 days postoperatively using 10-point visual analouge scale (VAS). (0-1=None, 2-4=mild, 5-7=moderate, 8-10=severe ).

Time frame
up to 7 days
2

change in edema scores

Edema will be assessed by a descriptive 4-point scale immediately post-operative, and at the 2nd,3rd,7th days postoperatively. Measured as follows: No inflammation = none. Intra oral swelling confined to the surgical field = mild. Extra oral swelling in the surgical zone =moderate. Extra oral swelling spreading beyond the surgical zone =intense.

Time frame
up to 7 days
3

change in bone density

Will be measured at 6 points around the implant and a mean value will be calculated

Time frame
up to 6 months

Other outcomes

Sponsors and contacts

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