Study comparing splitting and expanding alveolar bone of the lower jaw and placing bone constituent on one side with implant and direct implant placement.

Phase 3

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2025/05/086219

Lead Sponsor: Dr DY Patil dental college and hospital Pimpri Pune

Brief Summary: **Aim of the study:** To evaluate and comparealveolar ridge split and expansion with and without interpositional bone graftfor implant placement in mandibular region

**Objective of the study**

**1.** To increase horizontal width of alveolar ridge forimplant placement

**2.** To assess the boneregeneration levels after ridge split technique in knife edge ridges with bonegraft followed by immediate implant placement

**3.** To assess the boneregeneration levels after ridge split technique in knife edge ridges followedby immediate implant placement

**4.** To compare the boneregeneration levels in Group A and Group B

**Inclusion Criteria:**

**1.** Patientsrequiring dental implants

**2.** Alveolarbone width of 2-3mm

**3.** Alveolarbone of adequate height of 8-15mm

**4.** Patientswithin the age group of 18-60 years

**Exclusion Criteria:**

**1.** Patientswhose ridge shows excessive vertical resorption (<8mm)

**2.** Alveolarridge width >6mm

**3.** Patientsnot consenting to participate in the study

**4.** Immunocompromisedpatients

**Material and Methods**

**1.**Sterilegloves

**2.**Surgicaldrapes

**3.**2 %lignocaine injection with 1:200000 adrenaline

**4.**No15surgical Blade

**5.**Micromotorand burs

**6.**Osteotome

**7.**Chisel andmallets

**8.**Iwansoncalipers (buccolingual width)

**9.**UNC15 probe(mesiodistal width)

**10.**Xenograft

**11.**AdsonTissue holding forceps

**12.**Suturecutting scissors and short 6” Needle holder

**13.**3-0 silksuture

**14.**Pre and post (after8months) ridge expansion CBCT

**Source of the study**

**Type of study** – Comparative clinical study-

**In-vitro/In vivo/Survey:** In vivo

**Source from where the study material willbe selected:** Patientsreporting to Department of Oral and Maxillofacial Surgery, Dr. D. Y. PatilDental College, Pimpri, Pune

**Name and place where the study will beconducted**: Department of Oral and Maxillofacial Surgery,Dr. D. Y. Patil Dental College, Pimpri, Pune

**Method of data collection**

**Sampling technique used:** SIMPLE RANDOM SAMPLING

**Sample size: N=10**

**Size of eachgroup: n=5 sites**

**Group A: n=5**(ridge split and expansion followed by bone graft and implant placement)

**Group B: n=5** (ridgesplit and expansion followed by immediate implant placement)

**Study Design:** Randomized Control Trial

**Describe how the studywill be done in a step-wise chronological sequence:**

1.    Local anesthesia is administered at the site of theprocedure

2.    Incision using a no15 surgical blade is madefollowed by reflection of the flap

3.    Micromotor and burs are usedto drill the bone and create space for the chisel and mallet with simultaneoususe of osteotomes

4.    Bone width is checked using Iwansoncaliper buccolingually and UNC15 probe mesiodistally

5.    The space is then filledwith xenograft in group A and direct implant placement in group B followed byAbGel placement

6.    Socket is closed by figureof 8 sutures with 3-0 black silk suture in both the groups

**Duration of study**: 1 year

**Does the study requireany investigation or intervention to be made on patients, any human or animals*?*Yes**

**If Yes, briefly describe**:

Ridge with decreased horizontal width will be splitand expanded to achieve desired width for implant placement

**Investigations required**: CBCT, Routine bloodinvestigations

**Parameter(s) to be assessed instudy:**

1.   Horizontal widthof alveolar ridge using Iwanson caliper for buccolingual width and UNC 15 probefor mesiodistal distance

2.   Boneregeneration levels with and without bone graft using CBCT in pre andpost(after 8months) ridge split and expansion

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

1.Patients requiring dental implants 2.Alveolar bone width of 2-3mm 3.Alveolar bone of adequate height of 8-15mm 4.Patients within the age group of 18-60 years.

Exclusion Criteria

Patients whose ridge shows excessive vertical resorption (less than 8 mm) 2.
Alveolar ridge width above 6 mm 3.Patients not consenting to participate in the study 4.Immunocompromised patients.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2. To assess the bone regeneration levels after ridge splitting technique in knife edge ridges with bone graft followed by immediate implant placement	0, 8weeks
1. To increase horizontal width of alveolar ridge for implant placement	0, 8weeks
3. To assess the bone regeneration levels after ridge splitting technique in knife edge ridges followed by immediate implant placement	0, 8weeks
4. To compare the bone regeneration levels in Group A and Group B	0, 8weeks

Secondary Outcome Measures

Name	Time	Method
implant stability	0, 7weeks, 16weeks

Trial Locations

Locations (1): Dr DY Patil dental college and hospital, Pimpri, Pune
🇮🇳
Pune, MAHARASHTRA, India
Dr DY Patil dental college and hospital, Pimpri, Pune
🇮🇳Pune, MAHARASHTRA, India
Vrinda Rajagopal
Principal investigator
9633392138
23040111.dental@dpu.edu.in